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Banana Boat recalls scalp sunscreen spray
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The company announced a voluntary recall for three batches of the Banana Boat Hair & Scalp Spray SPF 30, which came in 6-ounce bottles and was sold across the U.S. through various retailers and online, according to a recall alert by the Food and Drug Administration.
The three batches have a UPC label of 0-79656-04041-8 and fall under the lot codes 20016AF, 20084BF, and 21139AF, with the expiration dates of December 2022, February 2023, and April 2024, respectively.
“An internal review found that some samples of the product contained trace levels of benzene. While benzene is not an ingredient in any Banana Boat products, the review showed the unexpected levels of benzene came from the propellant that sprays the product out of the can,” according to the recall notice.
“Importantly, no other batches of Hair & Scalp (either before or after these batch codes) and no other Banana Boat products are in the scope of this recall and may continue to be used by consumers safely and as intended,” the company wrote.
Benzene is classified as a human carcinogen, the FDA wrote. Exposure to benzene can occur through the nose, mouth, and skin, and it can result in serious conditions such as leukemia, bone marrow cancer, and blood disorders.
“Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources,” the company said. “Daily exposure to benzene in the recalled products would not be expected to cause adverse health consequences according to an independent health assessment using established exposure modeling guidelines.”
Edgewell said it hasn’t received any reports of bad events related to the recall. The company has told retailers to remove the affected batches from shelves.
Banana Boat will reimburse consumers who purchased a product with one of the affected lot codes, which are on the bottom of the can. In the meantime, consumers should stop using the affected product right away and discard it.
The recall comes a little over a year after Johnson & Johnson recalled five sunscreens due to low levels of benzene, according to The Associated Press. That recall included Aveeno and Neutrogena products in spray cans.
Consumers with questions about the recall can contact Edgewell Personal Care at 888-686-3988 Monday through Friday, 9 a.m. to 6 p.m. ET. People can also read more at the Banana Boat FAQ page or file for a refund directly on the Banana Boat Recall page.
A version of this article first appeared on WebMD.com.
.
The company announced a voluntary recall for three batches of the Banana Boat Hair & Scalp Spray SPF 30, which came in 6-ounce bottles and was sold across the U.S. through various retailers and online, according to a recall alert by the Food and Drug Administration.
The three batches have a UPC label of 0-79656-04041-8 and fall under the lot codes 20016AF, 20084BF, and 21139AF, with the expiration dates of December 2022, February 2023, and April 2024, respectively.
“An internal review found that some samples of the product contained trace levels of benzene. While benzene is not an ingredient in any Banana Boat products, the review showed the unexpected levels of benzene came from the propellant that sprays the product out of the can,” according to the recall notice.
“Importantly, no other batches of Hair & Scalp (either before or after these batch codes) and no other Banana Boat products are in the scope of this recall and may continue to be used by consumers safely and as intended,” the company wrote.
Benzene is classified as a human carcinogen, the FDA wrote. Exposure to benzene can occur through the nose, mouth, and skin, and it can result in serious conditions such as leukemia, bone marrow cancer, and blood disorders.
“Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources,” the company said. “Daily exposure to benzene in the recalled products would not be expected to cause adverse health consequences according to an independent health assessment using established exposure modeling guidelines.”
Edgewell said it hasn’t received any reports of bad events related to the recall. The company has told retailers to remove the affected batches from shelves.
Banana Boat will reimburse consumers who purchased a product with one of the affected lot codes, which are on the bottom of the can. In the meantime, consumers should stop using the affected product right away and discard it.
The recall comes a little over a year after Johnson & Johnson recalled five sunscreens due to low levels of benzene, according to The Associated Press. That recall included Aveeno and Neutrogena products in spray cans.
Consumers with questions about the recall can contact Edgewell Personal Care at 888-686-3988 Monday through Friday, 9 a.m. to 6 p.m. ET. People can also read more at the Banana Boat FAQ page or file for a refund directly on the Banana Boat Recall page.
A version of this article first appeared on WebMD.com.
.
The company announced a voluntary recall for three batches of the Banana Boat Hair & Scalp Spray SPF 30, which came in 6-ounce bottles and was sold across the U.S. through various retailers and online, according to a recall alert by the Food and Drug Administration.
The three batches have a UPC label of 0-79656-04041-8 and fall under the lot codes 20016AF, 20084BF, and 21139AF, with the expiration dates of December 2022, February 2023, and April 2024, respectively.
“An internal review found that some samples of the product contained trace levels of benzene. While benzene is not an ingredient in any Banana Boat products, the review showed the unexpected levels of benzene came from the propellant that sprays the product out of the can,” according to the recall notice.
“Importantly, no other batches of Hair & Scalp (either before or after these batch codes) and no other Banana Boat products are in the scope of this recall and may continue to be used by consumers safely and as intended,” the company wrote.
Benzene is classified as a human carcinogen, the FDA wrote. Exposure to benzene can occur through the nose, mouth, and skin, and it can result in serious conditions such as leukemia, bone marrow cancer, and blood disorders.
“Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources,” the company said. “Daily exposure to benzene in the recalled products would not be expected to cause adverse health consequences according to an independent health assessment using established exposure modeling guidelines.”
Edgewell said it hasn’t received any reports of bad events related to the recall. The company has told retailers to remove the affected batches from shelves.
Banana Boat will reimburse consumers who purchased a product with one of the affected lot codes, which are on the bottom of the can. In the meantime, consumers should stop using the affected product right away and discard it.
The recall comes a little over a year after Johnson & Johnson recalled five sunscreens due to low levels of benzene, according to The Associated Press. That recall included Aveeno and Neutrogena products in spray cans.
Consumers with questions about the recall can contact Edgewell Personal Care at 888-686-3988 Monday through Friday, 9 a.m. to 6 p.m. ET. People can also read more at the Banana Boat FAQ page or file for a refund directly on the Banana Boat Recall page.
A version of this article first appeared on WebMD.com.
Topical roflumilast approved for psoriasis in adults and adolescents
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Roflumilast is a selective inhibitor of phosphodiesterase 4 (PDE4), the first approved for treating psoriasis, according to manufacturer Arcutis Biotherapeutics. The company announced the approval on July 29. Oral roflumilast (Daliresp ) was approved in 2011 for treating chronic obstructive pulmonary disease (COPD).“It’s a breakthrough topical therapy,” says Mark G. Lebwohl, MD, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, and principal investigator in trials of topical roflumilast. In an interview, Dr. Lebwohl noted that the treatment significantly reduced psoriasis symptoms in both short- and long-term trials.
In addition, two features of this treatment set it apart from other topical psoriasis treatments, he said. Roflumilast is not a steroid, so does not have the risk for topical steroid-related side effects associated with chronic use, and, in clinical trials, topical roflumilast was effective in treating psoriasis in intertriginous areas, including the buttocks, underarms, and beneath the breasts, which are difficult to treat.
FDA approval is based on data from two phase 3 randomized, double-blind, vehicle-controlled trials, according to Arcutis. The primary endpoint was Investigator Global Assessment (IGA) success, defined as clear or almost clear with at least a two-grade improvement from baseline, and at least a two-grade IGA score improvement from baseline at 8 weeks.
At 8 weeks, 42.4% and 37.5% of the patients treated with topical roflumilast achieved an IGA success rate compared with 6.1% and 6.9% in the control groups, respectively (P < .0001 for both studies).
Treated patients also experienced significant improvements compared with those in the vehicle groups in secondary endpoints in the trials: Those included Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index–75 (PASI-75), reductions in itch based on the Worst Itch–Numerical Rating Scale (WI-NRS), and self-reported psoriasis symptoms diary (PSD).
In the studies, 72% and 68% of patients treated with roflumilast met the I-IGA endpoint at 8 weeks versus 14% and 17%, respectively, of those on vehicle (P < .0001 for both studies).
In addition, by week 2, some participants treated with roflumilast had experienced reduced itchiness in both studies. At 8 weeks, among those with a WI-NRS score of 4 or more at baseline, 67% and 69% of the treated patients had at least a four-point reduction in the WI-NRS versus 26% and 33%, respectively, among those on vehicle (P < .0001 for both studies), according to the company.
In general, the cream was well tolerated. There were reports of diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application-site pain (1%), upper respiratory tract infections (1%), and urinary tract infections (1%). However, Dr. Lebwohl noted that these events were also observed in the control group.
“The study was unequivocal about the improvement in the intertriginous sites,” Dr. Lebwohl said. He contrasts that to the data from other nonsteroidal topicals, which he said can be associated with a rash or irritation in sensitive areas.
Dr. Lebwohl noted that PDE4 is an enzyme that increases inflammation and decreases anti-inflammatory mediators and that inhibiting PDE4 may interrupt some of the inflammation response responsible for psoriasis symptoms, as it has for other conditions such as atopic dermatitis. Data from the 8-week phase 3 trials and yearlong phase 2b, open-label studies support that hypothesis.
“I’m always excited for new psoriasis treatments to broaden our treatment armamentarium,” said Lauren E. Ploch, MD, a dermatologist who practices in Augusta, Ga., and Aiken, S.C., who was asked to comment on the approval.
Even a symptom that seems benign, like itching, Dr. Ploch added, can lead to reduced sleep and increased irritability. Referring to the data on the treatment in the sensitive, intertriginous areas, she noted that the skin in these areas is often thinner, so treatment with steroids can cause further thinning and damage to the skin. If roflumilast doesn’t cause burning, itching, or thinning, it will be a great option to treat these areas, she said in an interview. She was not involved in the trials.
Roflumilast cream will be marketed under the trade name Zoryve, and is expected to be available by mid-August, according to Arcutis.
Roflumilast cream is also under review in Canada for treatment of plaque psoriasis in adults and adolescents.
The studies were funded by Arcutis Biotherapeutics. Dr. Lebwohl reported receiving grant support and consulting fees from Arcutis. Dr. Ploch reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
.
Roflumilast is a selective inhibitor of phosphodiesterase 4 (PDE4), the first approved for treating psoriasis, according to manufacturer Arcutis Biotherapeutics. The company announced the approval on July 29. Oral roflumilast (Daliresp ) was approved in 2011 for treating chronic obstructive pulmonary disease (COPD).“It’s a breakthrough topical therapy,” says Mark G. Lebwohl, MD, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, and principal investigator in trials of topical roflumilast. In an interview, Dr. Lebwohl noted that the treatment significantly reduced psoriasis symptoms in both short- and long-term trials.
In addition, two features of this treatment set it apart from other topical psoriasis treatments, he said. Roflumilast is not a steroid, so does not have the risk for topical steroid-related side effects associated with chronic use, and, in clinical trials, topical roflumilast was effective in treating psoriasis in intertriginous areas, including the buttocks, underarms, and beneath the breasts, which are difficult to treat.
FDA approval is based on data from two phase 3 randomized, double-blind, vehicle-controlled trials, according to Arcutis. The primary endpoint was Investigator Global Assessment (IGA) success, defined as clear or almost clear with at least a two-grade improvement from baseline, and at least a two-grade IGA score improvement from baseline at 8 weeks.
At 8 weeks, 42.4% and 37.5% of the patients treated with topical roflumilast achieved an IGA success rate compared with 6.1% and 6.9% in the control groups, respectively (P < .0001 for both studies).
Treated patients also experienced significant improvements compared with those in the vehicle groups in secondary endpoints in the trials: Those included Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index–75 (PASI-75), reductions in itch based on the Worst Itch–Numerical Rating Scale (WI-NRS), and self-reported psoriasis symptoms diary (PSD).
In the studies, 72% and 68% of patients treated with roflumilast met the I-IGA endpoint at 8 weeks versus 14% and 17%, respectively, of those on vehicle (P < .0001 for both studies).
In addition, by week 2, some participants treated with roflumilast had experienced reduced itchiness in both studies. At 8 weeks, among those with a WI-NRS score of 4 or more at baseline, 67% and 69% of the treated patients had at least a four-point reduction in the WI-NRS versus 26% and 33%, respectively, among those on vehicle (P < .0001 for both studies), according to the company.
In general, the cream was well tolerated. There were reports of diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application-site pain (1%), upper respiratory tract infections (1%), and urinary tract infections (1%). However, Dr. Lebwohl noted that these events were also observed in the control group.
“The study was unequivocal about the improvement in the intertriginous sites,” Dr. Lebwohl said. He contrasts that to the data from other nonsteroidal topicals, which he said can be associated with a rash or irritation in sensitive areas.
Dr. Lebwohl noted that PDE4 is an enzyme that increases inflammation and decreases anti-inflammatory mediators and that inhibiting PDE4 may interrupt some of the inflammation response responsible for psoriasis symptoms, as it has for other conditions such as atopic dermatitis. Data from the 8-week phase 3 trials and yearlong phase 2b, open-label studies support that hypothesis.
“I’m always excited for new psoriasis treatments to broaden our treatment armamentarium,” said Lauren E. Ploch, MD, a dermatologist who practices in Augusta, Ga., and Aiken, S.C., who was asked to comment on the approval.
Even a symptom that seems benign, like itching, Dr. Ploch added, can lead to reduced sleep and increased irritability. Referring to the data on the treatment in the sensitive, intertriginous areas, she noted that the skin in these areas is often thinner, so treatment with steroids can cause further thinning and damage to the skin. If roflumilast doesn’t cause burning, itching, or thinning, it will be a great option to treat these areas, she said in an interview. She was not involved in the trials.
Roflumilast cream will be marketed under the trade name Zoryve, and is expected to be available by mid-August, according to Arcutis.
Roflumilast cream is also under review in Canada for treatment of plaque psoriasis in adults and adolescents.
The studies were funded by Arcutis Biotherapeutics. Dr. Lebwohl reported receiving grant support and consulting fees from Arcutis. Dr. Ploch reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
.
Roflumilast is a selective inhibitor of phosphodiesterase 4 (PDE4), the first approved for treating psoriasis, according to manufacturer Arcutis Biotherapeutics. The company announced the approval on July 29. Oral roflumilast (Daliresp ) was approved in 2011 for treating chronic obstructive pulmonary disease (COPD).“It’s a breakthrough topical therapy,” says Mark G. Lebwohl, MD, dean of clinical therapeutics and professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, and principal investigator in trials of topical roflumilast. In an interview, Dr. Lebwohl noted that the treatment significantly reduced psoriasis symptoms in both short- and long-term trials.
In addition, two features of this treatment set it apart from other topical psoriasis treatments, he said. Roflumilast is not a steroid, so does not have the risk for topical steroid-related side effects associated with chronic use, and, in clinical trials, topical roflumilast was effective in treating psoriasis in intertriginous areas, including the buttocks, underarms, and beneath the breasts, which are difficult to treat.
FDA approval is based on data from two phase 3 randomized, double-blind, vehicle-controlled trials, according to Arcutis. The primary endpoint was Investigator Global Assessment (IGA) success, defined as clear or almost clear with at least a two-grade improvement from baseline, and at least a two-grade IGA score improvement from baseline at 8 weeks.
At 8 weeks, 42.4% and 37.5% of the patients treated with topical roflumilast achieved an IGA success rate compared with 6.1% and 6.9% in the control groups, respectively (P < .0001 for both studies).
Treated patients also experienced significant improvements compared with those in the vehicle groups in secondary endpoints in the trials: Those included Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index–75 (PASI-75), reductions in itch based on the Worst Itch–Numerical Rating Scale (WI-NRS), and self-reported psoriasis symptoms diary (PSD).
In the studies, 72% and 68% of patients treated with roflumilast met the I-IGA endpoint at 8 weeks versus 14% and 17%, respectively, of those on vehicle (P < .0001 for both studies).
In addition, by week 2, some participants treated with roflumilast had experienced reduced itchiness in both studies. At 8 weeks, among those with a WI-NRS score of 4 or more at baseline, 67% and 69% of the treated patients had at least a four-point reduction in the WI-NRS versus 26% and 33%, respectively, among those on vehicle (P < .0001 for both studies), according to the company.
In general, the cream was well tolerated. There were reports of diarrhea (3%), headache (2%), insomnia (1%), nausea (1%), application-site pain (1%), upper respiratory tract infections (1%), and urinary tract infections (1%). However, Dr. Lebwohl noted that these events were also observed in the control group.
“The study was unequivocal about the improvement in the intertriginous sites,” Dr. Lebwohl said. He contrasts that to the data from other nonsteroidal topicals, which he said can be associated with a rash or irritation in sensitive areas.
Dr. Lebwohl noted that PDE4 is an enzyme that increases inflammation and decreases anti-inflammatory mediators and that inhibiting PDE4 may interrupt some of the inflammation response responsible for psoriasis symptoms, as it has for other conditions such as atopic dermatitis. Data from the 8-week phase 3 trials and yearlong phase 2b, open-label studies support that hypothesis.
“I’m always excited for new psoriasis treatments to broaden our treatment armamentarium,” said Lauren E. Ploch, MD, a dermatologist who practices in Augusta, Ga., and Aiken, S.C., who was asked to comment on the approval.
Even a symptom that seems benign, like itching, Dr. Ploch added, can lead to reduced sleep and increased irritability. Referring to the data on the treatment in the sensitive, intertriginous areas, she noted that the skin in these areas is often thinner, so treatment with steroids can cause further thinning and damage to the skin. If roflumilast doesn’t cause burning, itching, or thinning, it will be a great option to treat these areas, she said in an interview. She was not involved in the trials.
Roflumilast cream will be marketed under the trade name Zoryve, and is expected to be available by mid-August, according to Arcutis.
Roflumilast cream is also under review in Canada for treatment of plaque psoriasis in adults and adolescents.
The studies were funded by Arcutis Biotherapeutics. Dr. Lebwohl reported receiving grant support and consulting fees from Arcutis. Dr. Ploch reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA panel urges caution with skin cancer–detecting tools
A and how to address longstanding issues of racial equity in this field of medicine.
The Food and Drug Administration has scheduled two meetings to gather expert feedback about managing an expected expansion in the use of skin lesion apps and devices. Outside of the United States, there are apps promoted as being able to help spot skin lesions that should trigger a medical visit.
The general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee began work on this topic on July 28, with a wide-ranging discussion about potential expanded use of computer-aided, skin lesion analyzer (SLA) devices. On Friday, the panel is considering an FDA proposal to shift the designation for an approved device for aiding dermatologists in skin cancer diagnoses from the most stringent regulatory category, class III, to the less restrictive class II.
The FDA called the meeting amid growing interest in using technology to aid in finding cancers, with some of these products already marketed to consumers outside of the United States. There are presently no legally marketed, FDA-cleared or FDA-approved SLA devices indicated for use by clinicians other than dermatologists or the lay public, the agency said in a briefing memo for the meeting. There are two devices with FDA approval, though, for aiding dermatologists. The FDA approved SciBase’s Nevisense in 2017 and Mela Sciences’ MelaFind, which has fallen out of use, in 2012. Both are class III devices.
But some companies intend to offer products for consumers in the United States. The company SkinVision, for example, has developed an app of the same name, which is intended to detect suspicious-looking skin spots via smartphone photos. SkinVision’s website says the product has been offered to consumers in Australia for remote skin checks since 2015. People in the Netherlands and United Kingdom also can use SkinVision, according to the company’s website. SkinVision says the company is working on providing the app for U.S. customers, “but we are not quite there yet.”
During the meeting, FDA panelists repeatedly emphasized the potential risks of these devices in terms of sensitivity (how often a test correctly generates a positive result) and of specificity (how often a test correctly generates a negative result).
New tools intended to aid in detection of skin cancer might produce too many false positives and thus trigger floods of worried patients seeking care and often facing unnecessary biopsies, the FDA panelists said. But more worrisome would be FDA clearance of tools that delivered too many false negative results, leaving people unaware of their cancers.
The standards would have to be set very high for new products, especially those intended for consumers, said FDA panelist Murad Alam, MD, a dermatologist and vice chair of the department of dermatology at Northwestern University, Chicago. Current technologies for analyzing skin lesions are not yet up to that task. Dr. Alam likened the situation to the hopes for self-driving cars.
“It sounds great in principle. If you read the predictions from 20 years ago, it should already have happened,” Dr. Alam said. “But we’re still struggling with that because there are serious points of failure.”
FDA panelist Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York, also argued for well-designed studies to understand how consumers and clinicians would react to new tools.
“We have to define what prospective information, in the intended use setting, we need to feel comfortable saying that these tools could be in a layperson’s hand or a primary care person’s hand,” Dr. Rotemberg said.
The studies would not need to be large, especially in the case of nonmelanoma skin cancer, which is common, she added.
“There’s too much nuance here for us to be able to say: ‘This is what would happen,’ without testing it,” Dr. Rotemberg said. “I do not think these prospective studies would be very burdensome, but they would help us understand what the burden would be and what the costs would be and what the potential harms would be.”
Because of rules against disclosing corporate information, the FDA cannot tell the public about the kinds of inquiries it already may have fielded from companies interested in selling skin cancer detection tools.
But in response to a question during the FDA meeting, Binita Ashar, MD, a top official in the FDA’s Center for Devices and Radiological Health, said there is interest in having these kinds of products sold in the United States as well.
“I can tell you that this a very timely discussion and questions that we’re posing to you are the questions that we’re encountering or that we have been grappling with,” Dr. Ashar said.
FDA panelists noted that many patients cannot get access easily to dermatology visits.
Companies seeking to develop SLA devices likely will market their tools as attempts to fill a gap that now exists in medical care.
But there will be challenges ahead in explaining to patients how to interpret readings from these tools, the FDA panelists said. Consumers should know these tools are meant to assist in diagnosis, and not to make it.
“I’m not sure the layperson will hear that,” said FDA panelist Paula E. Bourelly, MD, a dermatologist from Olney, Md.
As a result, use of SLA tools could create tension between physicians and patients, with consumers demanding biopsies after seeing readings they don’t understand.
“I do have great concerns about the layperson feeling overly confident and reducing the provider to a technician,” she said.
The FDA panelists were not asked to cast formal votes on any issues discussed during the meeting They instead engaged in broad discussions around questions posed by the FDA in three key areas:
- What standards should be used to confirm lesion diagnosis in clinical testing of the accuracy of SLA devices?
- What would be acceptable true false-positive and false-negative results (sensitivity and specificity) for different diagnoses and users?
- How can the FDA address health equity considerations based on variable incidence of skin lesions?
Developing standards
The FDA asked the panel to consider several scenarios for SLA devices and to discuss how standards might vary depending on the user of the device, whether it would be dermatologists, other clinicians, or consumers.
The agency sought comments in particular about using histological diagnosis (core specimen processing with a consensus diagnosis from an expert dermatopathologist panel). In the briefing document for the meeting, the FDA argued that this approach provides the greatest certainty in the diagnosis.
“Device developers, however, cite concerns, both practical and ethical, in requiring biopsy of all lesions, particularly those that appear benign,” the FDA said. “They have proposed alternate means of defining ground truth, including consensus opinion of experts (of visual or dermoscopic examination of the lesion[s]), opinion of one expert (visual or dermoscopic examination), or other methods.”
In summarizing the discussion on this question, the FDA panel chairman, Hobart W. Harris, MD, MPH, a surgeon from the University of California, San Francisco, noted that there was broad support for histological data in clinical trials of SLA devices, with some allowance for cases where more hybrid approaches would be used.
There were also suggestions offered about designing trials and the need for biopsies of lesions that are clearly benign, as this would help gather data to help in developing algorithms.
Dr. Alam said care should be taken in explaining to study participants that they might have to undergo biopsies that they didn’t need, as part of the larger effort to gather data. This should be detailed in the consent form, he said.
“But I also think this is a relatively minor risk,” Dr. Alam said, comparing these biopsies to the blood samples that patients in many clinical studies routinely give.
“Are all of those blood draws necessary to track the change in whatever parameters that are being tracked? Probably not,” Dr. Alam said. “I think it would be possible to explain to a reasonable patient what this entails.”
Dr. Alam noted that companies might face extra hurdles in enrolling study participants and keeping them in the trials if the FDA seeks this kind of biopsy data. “But I don’t think inconvenience to the study sponsor is a good argument” for not seeking this kind of data, he added.
Leaving a loophole where certain kinds of clearly benign lesions don’t require a biopsy would eventually erode the quality of the research done on these devices. “That bar will be moved to accommodate the convenience of the sponsor, to make the study feasible,” Dr. Alam said. “And pretty soon, you’ll be missing a lot of patients that really should have biopsies.”
Acceptable rates of false positives, false negatives
The FDA panel chair noted that his colleagues had strongly urged review standards that would require that the devices improve on the rates of successful catches of suspicious lesions and lower false positives. But they did not endorse specific targets regarding the sensitivity and specificity rates.
“No one seems to be comfortable with providing or preordaining” these targets, Dr. Harris said.
Panelist Deneen Hesser, MSHSA, RN, urged a deep recognition of the power of a FDA clearance in the view of consumers.
“We need to be cognizant of what the term ‘FDA approved’ means to the lay individual,” said Ms. Hesser, who served as the patient representative on the panel. “A patient who sees that those tools are FDA approved will assume that each of those is the gold standard” in terms of expectations for delivering accurate results.
Like many of the panelists, Dr. Rotemberg urged the FDA to gather data about how patients would react to different messages encoded in consumer-oriented products.
“If the device says: ‘You should see a dermatologist for this’ and no other information, that’s very different from [saying]: ‘That lesion is suspicious for melanoma,’ ” Dr. Rotemberg said.
Despite the likely difficulties in conducting trials, the FDA needs to have the data to answer key questions about patient and physician reactions to readings from new tools, Dr. Rotemberg said.
“We don’t know how many additional biopsies we would cause with a specificity of 80%” for a new SLA tool, Dr. Rotemberg said, giving an example. “We don’t know how confident a dermatologist might be to say: ‘Actually, I’m not suspicious about that lesion and we can just fudge it or not biopsy it.’ We don’t know any of that until we study it in real life.”
The panelists also urged the FDA to seek to ensure that new tools used in analyzing skin lesions improve the quality of diagnosis.
Addressing equity
The FDA also asked the panel to weigh in on whether the agency should clear SLA tools in cases where the existing study data is drawn heavily from people considered to be at higher risk for skin cancer.
“To ensure generalizability across the entire U.S. population, should FDA require SLAs indicated for use beyond cancerous lesions be tested in a representative U.S. population?” the FDA asked.
The three most common skin cancers – melanoma, basal cell carcinoma, and squamous cell carcinoma – are more prevalent in people with Fitzpatrick I and II skin types, who tend to get sunburns, not tans. But people of color are more likely to develop melanoma in areas that are not sun exposed, such as the sole of the foot or under fingernails or toenails.
“Due in part to lower expected risk and screening, these melanomas are often detected late,” the FDA said in the briefing document.
There was broad consensus among panelists that the FDA should encourage companies to enroll people with all skin types and tones.
But they also looked for ways that the FDA could clear devices based on initial studies conducted largely with people considered to be at higher risk, with the agency then requiring follow-up trials to see how these products would work for the general U.S. population.
A version of this article first appeared on Medscape.com.
A and how to address longstanding issues of racial equity in this field of medicine.
The Food and Drug Administration has scheduled two meetings to gather expert feedback about managing an expected expansion in the use of skin lesion apps and devices. Outside of the United States, there are apps promoted as being able to help spot skin lesions that should trigger a medical visit.
The general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee began work on this topic on July 28, with a wide-ranging discussion about potential expanded use of computer-aided, skin lesion analyzer (SLA) devices. On Friday, the panel is considering an FDA proposal to shift the designation for an approved device for aiding dermatologists in skin cancer diagnoses from the most stringent regulatory category, class III, to the less restrictive class II.
The FDA called the meeting amid growing interest in using technology to aid in finding cancers, with some of these products already marketed to consumers outside of the United States. There are presently no legally marketed, FDA-cleared or FDA-approved SLA devices indicated for use by clinicians other than dermatologists or the lay public, the agency said in a briefing memo for the meeting. There are two devices with FDA approval, though, for aiding dermatologists. The FDA approved SciBase’s Nevisense in 2017 and Mela Sciences’ MelaFind, which has fallen out of use, in 2012. Both are class III devices.
But some companies intend to offer products for consumers in the United States. The company SkinVision, for example, has developed an app of the same name, which is intended to detect suspicious-looking skin spots via smartphone photos. SkinVision’s website says the product has been offered to consumers in Australia for remote skin checks since 2015. People in the Netherlands and United Kingdom also can use SkinVision, according to the company’s website. SkinVision says the company is working on providing the app for U.S. customers, “but we are not quite there yet.”
During the meeting, FDA panelists repeatedly emphasized the potential risks of these devices in terms of sensitivity (how often a test correctly generates a positive result) and of specificity (how often a test correctly generates a negative result).
New tools intended to aid in detection of skin cancer might produce too many false positives and thus trigger floods of worried patients seeking care and often facing unnecessary biopsies, the FDA panelists said. But more worrisome would be FDA clearance of tools that delivered too many false negative results, leaving people unaware of their cancers.
The standards would have to be set very high for new products, especially those intended for consumers, said FDA panelist Murad Alam, MD, a dermatologist and vice chair of the department of dermatology at Northwestern University, Chicago. Current technologies for analyzing skin lesions are not yet up to that task. Dr. Alam likened the situation to the hopes for self-driving cars.
“It sounds great in principle. If you read the predictions from 20 years ago, it should already have happened,” Dr. Alam said. “But we’re still struggling with that because there are serious points of failure.”
FDA panelist Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York, also argued for well-designed studies to understand how consumers and clinicians would react to new tools.
“We have to define what prospective information, in the intended use setting, we need to feel comfortable saying that these tools could be in a layperson’s hand or a primary care person’s hand,” Dr. Rotemberg said.
The studies would not need to be large, especially in the case of nonmelanoma skin cancer, which is common, she added.
“There’s too much nuance here for us to be able to say: ‘This is what would happen,’ without testing it,” Dr. Rotemberg said. “I do not think these prospective studies would be very burdensome, but they would help us understand what the burden would be and what the costs would be and what the potential harms would be.”
Because of rules against disclosing corporate information, the FDA cannot tell the public about the kinds of inquiries it already may have fielded from companies interested in selling skin cancer detection tools.
But in response to a question during the FDA meeting, Binita Ashar, MD, a top official in the FDA’s Center for Devices and Radiological Health, said there is interest in having these kinds of products sold in the United States as well.
“I can tell you that this a very timely discussion and questions that we’re posing to you are the questions that we’re encountering or that we have been grappling with,” Dr. Ashar said.
FDA panelists noted that many patients cannot get access easily to dermatology visits.
Companies seeking to develop SLA devices likely will market their tools as attempts to fill a gap that now exists in medical care.
But there will be challenges ahead in explaining to patients how to interpret readings from these tools, the FDA panelists said. Consumers should know these tools are meant to assist in diagnosis, and not to make it.
“I’m not sure the layperson will hear that,” said FDA panelist Paula E. Bourelly, MD, a dermatologist from Olney, Md.
As a result, use of SLA tools could create tension between physicians and patients, with consumers demanding biopsies after seeing readings they don’t understand.
“I do have great concerns about the layperson feeling overly confident and reducing the provider to a technician,” she said.
The FDA panelists were not asked to cast formal votes on any issues discussed during the meeting They instead engaged in broad discussions around questions posed by the FDA in three key areas:
- What standards should be used to confirm lesion diagnosis in clinical testing of the accuracy of SLA devices?
- What would be acceptable true false-positive and false-negative results (sensitivity and specificity) for different diagnoses and users?
- How can the FDA address health equity considerations based on variable incidence of skin lesions?
Developing standards
The FDA asked the panel to consider several scenarios for SLA devices and to discuss how standards might vary depending on the user of the device, whether it would be dermatologists, other clinicians, or consumers.
The agency sought comments in particular about using histological diagnosis (core specimen processing with a consensus diagnosis from an expert dermatopathologist panel). In the briefing document for the meeting, the FDA argued that this approach provides the greatest certainty in the diagnosis.
“Device developers, however, cite concerns, both practical and ethical, in requiring biopsy of all lesions, particularly those that appear benign,” the FDA said. “They have proposed alternate means of defining ground truth, including consensus opinion of experts (of visual or dermoscopic examination of the lesion[s]), opinion of one expert (visual or dermoscopic examination), or other methods.”
In summarizing the discussion on this question, the FDA panel chairman, Hobart W. Harris, MD, MPH, a surgeon from the University of California, San Francisco, noted that there was broad support for histological data in clinical trials of SLA devices, with some allowance for cases where more hybrid approaches would be used.
There were also suggestions offered about designing trials and the need for biopsies of lesions that are clearly benign, as this would help gather data to help in developing algorithms.
Dr. Alam said care should be taken in explaining to study participants that they might have to undergo biopsies that they didn’t need, as part of the larger effort to gather data. This should be detailed in the consent form, he said.
“But I also think this is a relatively minor risk,” Dr. Alam said, comparing these biopsies to the blood samples that patients in many clinical studies routinely give.
“Are all of those blood draws necessary to track the change in whatever parameters that are being tracked? Probably not,” Dr. Alam said. “I think it would be possible to explain to a reasonable patient what this entails.”
Dr. Alam noted that companies might face extra hurdles in enrolling study participants and keeping them in the trials if the FDA seeks this kind of biopsy data. “But I don’t think inconvenience to the study sponsor is a good argument” for not seeking this kind of data, he added.
Leaving a loophole where certain kinds of clearly benign lesions don’t require a biopsy would eventually erode the quality of the research done on these devices. “That bar will be moved to accommodate the convenience of the sponsor, to make the study feasible,” Dr. Alam said. “And pretty soon, you’ll be missing a lot of patients that really should have biopsies.”
Acceptable rates of false positives, false negatives
The FDA panel chair noted that his colleagues had strongly urged review standards that would require that the devices improve on the rates of successful catches of suspicious lesions and lower false positives. But they did not endorse specific targets regarding the sensitivity and specificity rates.
“No one seems to be comfortable with providing or preordaining” these targets, Dr. Harris said.
Panelist Deneen Hesser, MSHSA, RN, urged a deep recognition of the power of a FDA clearance in the view of consumers.
“We need to be cognizant of what the term ‘FDA approved’ means to the lay individual,” said Ms. Hesser, who served as the patient representative on the panel. “A patient who sees that those tools are FDA approved will assume that each of those is the gold standard” in terms of expectations for delivering accurate results.
Like many of the panelists, Dr. Rotemberg urged the FDA to gather data about how patients would react to different messages encoded in consumer-oriented products.
“If the device says: ‘You should see a dermatologist for this’ and no other information, that’s very different from [saying]: ‘That lesion is suspicious for melanoma,’ ” Dr. Rotemberg said.
Despite the likely difficulties in conducting trials, the FDA needs to have the data to answer key questions about patient and physician reactions to readings from new tools, Dr. Rotemberg said.
“We don’t know how many additional biopsies we would cause with a specificity of 80%” for a new SLA tool, Dr. Rotemberg said, giving an example. “We don’t know how confident a dermatologist might be to say: ‘Actually, I’m not suspicious about that lesion and we can just fudge it or not biopsy it.’ We don’t know any of that until we study it in real life.”
The panelists also urged the FDA to seek to ensure that new tools used in analyzing skin lesions improve the quality of diagnosis.
Addressing equity
The FDA also asked the panel to weigh in on whether the agency should clear SLA tools in cases where the existing study data is drawn heavily from people considered to be at higher risk for skin cancer.
“To ensure generalizability across the entire U.S. population, should FDA require SLAs indicated for use beyond cancerous lesions be tested in a representative U.S. population?” the FDA asked.
The three most common skin cancers – melanoma, basal cell carcinoma, and squamous cell carcinoma – are more prevalent in people with Fitzpatrick I and II skin types, who tend to get sunburns, not tans. But people of color are more likely to develop melanoma in areas that are not sun exposed, such as the sole of the foot or under fingernails or toenails.
“Due in part to lower expected risk and screening, these melanomas are often detected late,” the FDA said in the briefing document.
There was broad consensus among panelists that the FDA should encourage companies to enroll people with all skin types and tones.
But they also looked for ways that the FDA could clear devices based on initial studies conducted largely with people considered to be at higher risk, with the agency then requiring follow-up trials to see how these products would work for the general U.S. population.
A version of this article first appeared on Medscape.com.
A and how to address longstanding issues of racial equity in this field of medicine.
The Food and Drug Administration has scheduled two meetings to gather expert feedback about managing an expected expansion in the use of skin lesion apps and devices. Outside of the United States, there are apps promoted as being able to help spot skin lesions that should trigger a medical visit.
The general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee began work on this topic on July 28, with a wide-ranging discussion about potential expanded use of computer-aided, skin lesion analyzer (SLA) devices. On Friday, the panel is considering an FDA proposal to shift the designation for an approved device for aiding dermatologists in skin cancer diagnoses from the most stringent regulatory category, class III, to the less restrictive class II.
The FDA called the meeting amid growing interest in using technology to aid in finding cancers, with some of these products already marketed to consumers outside of the United States. There are presently no legally marketed, FDA-cleared or FDA-approved SLA devices indicated for use by clinicians other than dermatologists or the lay public, the agency said in a briefing memo for the meeting. There are two devices with FDA approval, though, for aiding dermatologists. The FDA approved SciBase’s Nevisense in 2017 and Mela Sciences’ MelaFind, which has fallen out of use, in 2012. Both are class III devices.
But some companies intend to offer products for consumers in the United States. The company SkinVision, for example, has developed an app of the same name, which is intended to detect suspicious-looking skin spots via smartphone photos. SkinVision’s website says the product has been offered to consumers in Australia for remote skin checks since 2015. People in the Netherlands and United Kingdom also can use SkinVision, according to the company’s website. SkinVision says the company is working on providing the app for U.S. customers, “but we are not quite there yet.”
During the meeting, FDA panelists repeatedly emphasized the potential risks of these devices in terms of sensitivity (how often a test correctly generates a positive result) and of specificity (how often a test correctly generates a negative result).
New tools intended to aid in detection of skin cancer might produce too many false positives and thus trigger floods of worried patients seeking care and often facing unnecessary biopsies, the FDA panelists said. But more worrisome would be FDA clearance of tools that delivered too many false negative results, leaving people unaware of their cancers.
The standards would have to be set very high for new products, especially those intended for consumers, said FDA panelist Murad Alam, MD, a dermatologist and vice chair of the department of dermatology at Northwestern University, Chicago. Current technologies for analyzing skin lesions are not yet up to that task. Dr. Alam likened the situation to the hopes for self-driving cars.
“It sounds great in principle. If you read the predictions from 20 years ago, it should already have happened,” Dr. Alam said. “But we’re still struggling with that because there are serious points of failure.”
FDA panelist Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York, also argued for well-designed studies to understand how consumers and clinicians would react to new tools.
“We have to define what prospective information, in the intended use setting, we need to feel comfortable saying that these tools could be in a layperson’s hand or a primary care person’s hand,” Dr. Rotemberg said.
The studies would not need to be large, especially in the case of nonmelanoma skin cancer, which is common, she added.
“There’s too much nuance here for us to be able to say: ‘This is what would happen,’ without testing it,” Dr. Rotemberg said. “I do not think these prospective studies would be very burdensome, but they would help us understand what the burden would be and what the costs would be and what the potential harms would be.”
Because of rules against disclosing corporate information, the FDA cannot tell the public about the kinds of inquiries it already may have fielded from companies interested in selling skin cancer detection tools.
But in response to a question during the FDA meeting, Binita Ashar, MD, a top official in the FDA’s Center for Devices and Radiological Health, said there is interest in having these kinds of products sold in the United States as well.
“I can tell you that this a very timely discussion and questions that we’re posing to you are the questions that we’re encountering or that we have been grappling with,” Dr. Ashar said.
FDA panelists noted that many patients cannot get access easily to dermatology visits.
Companies seeking to develop SLA devices likely will market their tools as attempts to fill a gap that now exists in medical care.
But there will be challenges ahead in explaining to patients how to interpret readings from these tools, the FDA panelists said. Consumers should know these tools are meant to assist in diagnosis, and not to make it.
“I’m not sure the layperson will hear that,” said FDA panelist Paula E. Bourelly, MD, a dermatologist from Olney, Md.
As a result, use of SLA tools could create tension between physicians and patients, with consumers demanding biopsies after seeing readings they don’t understand.
“I do have great concerns about the layperson feeling overly confident and reducing the provider to a technician,” she said.
The FDA panelists were not asked to cast formal votes on any issues discussed during the meeting They instead engaged in broad discussions around questions posed by the FDA in three key areas:
- What standards should be used to confirm lesion diagnosis in clinical testing of the accuracy of SLA devices?
- What would be acceptable true false-positive and false-negative results (sensitivity and specificity) for different diagnoses and users?
- How can the FDA address health equity considerations based on variable incidence of skin lesions?
Developing standards
The FDA asked the panel to consider several scenarios for SLA devices and to discuss how standards might vary depending on the user of the device, whether it would be dermatologists, other clinicians, or consumers.
The agency sought comments in particular about using histological diagnosis (core specimen processing with a consensus diagnosis from an expert dermatopathologist panel). In the briefing document for the meeting, the FDA argued that this approach provides the greatest certainty in the diagnosis.
“Device developers, however, cite concerns, both practical and ethical, in requiring biopsy of all lesions, particularly those that appear benign,” the FDA said. “They have proposed alternate means of defining ground truth, including consensus opinion of experts (of visual or dermoscopic examination of the lesion[s]), opinion of one expert (visual or dermoscopic examination), or other methods.”
In summarizing the discussion on this question, the FDA panel chairman, Hobart W. Harris, MD, MPH, a surgeon from the University of California, San Francisco, noted that there was broad support for histological data in clinical trials of SLA devices, with some allowance for cases where more hybrid approaches would be used.
There were also suggestions offered about designing trials and the need for biopsies of lesions that are clearly benign, as this would help gather data to help in developing algorithms.
Dr. Alam said care should be taken in explaining to study participants that they might have to undergo biopsies that they didn’t need, as part of the larger effort to gather data. This should be detailed in the consent form, he said.
“But I also think this is a relatively minor risk,” Dr. Alam said, comparing these biopsies to the blood samples that patients in many clinical studies routinely give.
“Are all of those blood draws necessary to track the change in whatever parameters that are being tracked? Probably not,” Dr. Alam said. “I think it would be possible to explain to a reasonable patient what this entails.”
Dr. Alam noted that companies might face extra hurdles in enrolling study participants and keeping them in the trials if the FDA seeks this kind of biopsy data. “But I don’t think inconvenience to the study sponsor is a good argument” for not seeking this kind of data, he added.
Leaving a loophole where certain kinds of clearly benign lesions don’t require a biopsy would eventually erode the quality of the research done on these devices. “That bar will be moved to accommodate the convenience of the sponsor, to make the study feasible,” Dr. Alam said. “And pretty soon, you’ll be missing a lot of patients that really should have biopsies.”
Acceptable rates of false positives, false negatives
The FDA panel chair noted that his colleagues had strongly urged review standards that would require that the devices improve on the rates of successful catches of suspicious lesions and lower false positives. But they did not endorse specific targets regarding the sensitivity and specificity rates.
“No one seems to be comfortable with providing or preordaining” these targets, Dr. Harris said.
Panelist Deneen Hesser, MSHSA, RN, urged a deep recognition of the power of a FDA clearance in the view of consumers.
“We need to be cognizant of what the term ‘FDA approved’ means to the lay individual,” said Ms. Hesser, who served as the patient representative on the panel. “A patient who sees that those tools are FDA approved will assume that each of those is the gold standard” in terms of expectations for delivering accurate results.
Like many of the panelists, Dr. Rotemberg urged the FDA to gather data about how patients would react to different messages encoded in consumer-oriented products.
“If the device says: ‘You should see a dermatologist for this’ and no other information, that’s very different from [saying]: ‘That lesion is suspicious for melanoma,’ ” Dr. Rotemberg said.
Despite the likely difficulties in conducting trials, the FDA needs to have the data to answer key questions about patient and physician reactions to readings from new tools, Dr. Rotemberg said.
“We don’t know how many additional biopsies we would cause with a specificity of 80%” for a new SLA tool, Dr. Rotemberg said, giving an example. “We don’t know how confident a dermatologist might be to say: ‘Actually, I’m not suspicious about that lesion and we can just fudge it or not biopsy it.’ We don’t know any of that until we study it in real life.”
The panelists also urged the FDA to seek to ensure that new tools used in analyzing skin lesions improve the quality of diagnosis.
Addressing equity
The FDA also asked the panel to weigh in on whether the agency should clear SLA tools in cases where the existing study data is drawn heavily from people considered to be at higher risk for skin cancer.
“To ensure generalizability across the entire U.S. population, should FDA require SLAs indicated for use beyond cancerous lesions be tested in a representative U.S. population?” the FDA asked.
The three most common skin cancers – melanoma, basal cell carcinoma, and squamous cell carcinoma – are more prevalent in people with Fitzpatrick I and II skin types, who tend to get sunburns, not tans. But people of color are more likely to develop melanoma in areas that are not sun exposed, such as the sole of the foot or under fingernails or toenails.
“Due in part to lower expected risk and screening, these melanomas are often detected late,” the FDA said in the briefing document.
There was broad consensus among panelists that the FDA should encourage companies to enroll people with all skin types and tones.
But they also looked for ways that the FDA could clear devices based on initial studies conducted largely with people considered to be at higher risk, with the agency then requiring follow-up trials to see how these products would work for the general U.S. population.
A version of this article first appeared on Medscape.com.
FDA approves belimumab for children with lupus nephritis
The Food and Drug Administration has approved belimumab (Benlysta) for treating active lupus nephritis (LN) in children aged 5-17 years. The drug can now be used to treat adult and pediatric patients with systemic lupus erythematosus (SLE) and LN. The decision expands therapeutic options for the estimated 1.5 million Americans currently living with lupus.
“This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life,” Stevan W. Gibson, president and CEO of the Lupus Foundation of America, said in a press release issued by the manufacturer, GlaxoSmithKline. LN is a condition that sometimes develops in people with lupus. In LN, the autoimmune cells produced by the disease attack the kidney. Roughly 40% of people with SLE experience LN.
Damage to the kidneys causes the body to have difficulty processing waste and toxins. This can create a host of problems, including end-stage kidney disease, which may be treated only with dialysis or kidney transplant. These situations significantly increase mortality among people with lupus, especially children.
Prior to the approval, the only treatment pathway for children with active LN included immunosuppressants and corticosteroids. While they may be effective, use of these classes of drugs may come with many side effects, including susceptibility to other diseases and infections. Belimumab, by contrast, is a B-lymphocyte stimulator protein inhibitor. It inhibits the survival of B cells, which are thought to play a role in the disease’s pathophysiology.
Belimumab was first approved to treat patients with SLE in 2011. It was approved for children with SLE 8 years later. The drug’s indications were expanded to include adults with LN in 2020.
Organizations within the lupus research community have communicated their support of the FDA’s decision. “Our community has much to celebrate with the approval of the first and much-needed treatment for children with lupus nephritis,” Lupus Research Alliance President and CEO Kenneth M. Farber said in a release from the organization.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved belimumab (Benlysta) for treating active lupus nephritis (LN) in children aged 5-17 years. The drug can now be used to treat adult and pediatric patients with systemic lupus erythematosus (SLE) and LN. The decision expands therapeutic options for the estimated 1.5 million Americans currently living with lupus.
“This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life,” Stevan W. Gibson, president and CEO of the Lupus Foundation of America, said in a press release issued by the manufacturer, GlaxoSmithKline. LN is a condition that sometimes develops in people with lupus. In LN, the autoimmune cells produced by the disease attack the kidney. Roughly 40% of people with SLE experience LN.
Damage to the kidneys causes the body to have difficulty processing waste and toxins. This can create a host of problems, including end-stage kidney disease, which may be treated only with dialysis or kidney transplant. These situations significantly increase mortality among people with lupus, especially children.
Prior to the approval, the only treatment pathway for children with active LN included immunosuppressants and corticosteroids. While they may be effective, use of these classes of drugs may come with many side effects, including susceptibility to other diseases and infections. Belimumab, by contrast, is a B-lymphocyte stimulator protein inhibitor. It inhibits the survival of B cells, which are thought to play a role in the disease’s pathophysiology.
Belimumab was first approved to treat patients with SLE in 2011. It was approved for children with SLE 8 years later. The drug’s indications were expanded to include adults with LN in 2020.
Organizations within the lupus research community have communicated their support of the FDA’s decision. “Our community has much to celebrate with the approval of the first and much-needed treatment for children with lupus nephritis,” Lupus Research Alliance President and CEO Kenneth M. Farber said in a release from the organization.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved belimumab (Benlysta) for treating active lupus nephritis (LN) in children aged 5-17 years. The drug can now be used to treat adult and pediatric patients with systemic lupus erythematosus (SLE) and LN. The decision expands therapeutic options for the estimated 1.5 million Americans currently living with lupus.
“This approval marks a significant step forward in providing treatment options to these children at risk of incurring kidney damage early on in life,” Stevan W. Gibson, president and CEO of the Lupus Foundation of America, said in a press release issued by the manufacturer, GlaxoSmithKline. LN is a condition that sometimes develops in people with lupus. In LN, the autoimmune cells produced by the disease attack the kidney. Roughly 40% of people with SLE experience LN.
Damage to the kidneys causes the body to have difficulty processing waste and toxins. This can create a host of problems, including end-stage kidney disease, which may be treated only with dialysis or kidney transplant. These situations significantly increase mortality among people with lupus, especially children.
Prior to the approval, the only treatment pathway for children with active LN included immunosuppressants and corticosteroids. While they may be effective, use of these classes of drugs may come with many side effects, including susceptibility to other diseases and infections. Belimumab, by contrast, is a B-lymphocyte stimulator protein inhibitor. It inhibits the survival of B cells, which are thought to play a role in the disease’s pathophysiology.
Belimumab was first approved to treat patients with SLE in 2011. It was approved for children with SLE 8 years later. The drug’s indications were expanded to include adults with LN in 2020.
Organizations within the lupus research community have communicated their support of the FDA’s decision. “Our community has much to celebrate with the approval of the first and much-needed treatment for children with lupus nephritis,” Lupus Research Alliance President and CEO Kenneth M. Farber said in a release from the organization.
A version of this article first appeared on Medscape.com.
FDA clears endoscopic devices for sleeve gastroplasty, bariatric revision
The Food and Drug Administration has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.
The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, said in a news release.
“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” Mr. McKhann added.
The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.
The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.
Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20%-30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.
TORe is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.
The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, said in a news release.
“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” Mr. McKhann added.
The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.
The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.
Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20%-30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.
TORe is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.
The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, said in a news release.
“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” Mr. McKhann added.
The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.
The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.
Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20%-30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.
TORe is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.
A version of this article first appeared on Medscape.com.
CDC warns about potentially deadly virus in infants
The potentially fatal parechovirus is now circulating in multiple states, causing fevers, seizures, and sepsis-like symptoms, including confusion and extreme pain, according to the CDC.
Human parechoviruses are common in children and most have been infected before they start kindergarten, the CDC said. Between 6 months and 5 years of age, symptoms include an upper respiratory tract infection, fever, and rash.
But infants younger than 3 months may have more serious, and possibly fatal, infections. They may get “sepsis-like illness, seizures, and meningitis or meningoencephalitis, particularly in infants younger than 1 month,” the CDC said. At least one newborn has reportedly died from the infection.
Parechovirus can spread like other common germs, from feces that are later ingested – likely due to poor handwashing – and through droplets sent airborne by coughing or sneezing. It can be transmitted by people both with and without symptoms of the infection.
The microbe can reproduce for 1-3 weeks in the upper respiratory tract and up to 6 months in the gastrointestinal tract, the CDC said.
Kristina Angel Bryant, MD, a pediatric infectious disease specialist at the University of Louisville Hospital, says parechoviruses often cause rashes on the hands and feet, which some experts refer to as “mittens and booties.”
The CDC is urging doctors to test for parechovirus if they recognize these symptoms in infants if there is no other explanation for what might be distressing them.
There is no specific treatment for parechovirus. And with no standard testing system in place, experts are unsure if the number of parechovirus cases is higher in 2022 than in previous years.
The message for parents, Dr. Bryant says, is: Don’t panic. “This is not a new virus.”
“One of the most common symptoms is fever, and in some kids, that is the only symptom,” she says. “Older infants and toddlers may have only cold symptoms, and some kids have no symptoms at all.”
Parents can take the usual steps to protect their child from the viral illness, including diligent handwashing and having less contact with people who are sick, Dr. Bryant says.
A version of this article first appeared on Medscape.com.
The potentially fatal parechovirus is now circulating in multiple states, causing fevers, seizures, and sepsis-like symptoms, including confusion and extreme pain, according to the CDC.
Human parechoviruses are common in children and most have been infected before they start kindergarten, the CDC said. Between 6 months and 5 years of age, symptoms include an upper respiratory tract infection, fever, and rash.
But infants younger than 3 months may have more serious, and possibly fatal, infections. They may get “sepsis-like illness, seizures, and meningitis or meningoencephalitis, particularly in infants younger than 1 month,” the CDC said. At least one newborn has reportedly died from the infection.
Parechovirus can spread like other common germs, from feces that are later ingested – likely due to poor handwashing – and through droplets sent airborne by coughing or sneezing. It can be transmitted by people both with and without symptoms of the infection.
The microbe can reproduce for 1-3 weeks in the upper respiratory tract and up to 6 months in the gastrointestinal tract, the CDC said.
Kristina Angel Bryant, MD, a pediatric infectious disease specialist at the University of Louisville Hospital, says parechoviruses often cause rashes on the hands and feet, which some experts refer to as “mittens and booties.”
The CDC is urging doctors to test for parechovirus if they recognize these symptoms in infants if there is no other explanation for what might be distressing them.
There is no specific treatment for parechovirus. And with no standard testing system in place, experts are unsure if the number of parechovirus cases is higher in 2022 than in previous years.
The message for parents, Dr. Bryant says, is: Don’t panic. “This is not a new virus.”
“One of the most common symptoms is fever, and in some kids, that is the only symptom,” she says. “Older infants and toddlers may have only cold symptoms, and some kids have no symptoms at all.”
Parents can take the usual steps to protect their child from the viral illness, including diligent handwashing and having less contact with people who are sick, Dr. Bryant says.
A version of this article first appeared on Medscape.com.
The potentially fatal parechovirus is now circulating in multiple states, causing fevers, seizures, and sepsis-like symptoms, including confusion and extreme pain, according to the CDC.
Human parechoviruses are common in children and most have been infected before they start kindergarten, the CDC said. Between 6 months and 5 years of age, symptoms include an upper respiratory tract infection, fever, and rash.
But infants younger than 3 months may have more serious, and possibly fatal, infections. They may get “sepsis-like illness, seizures, and meningitis or meningoencephalitis, particularly in infants younger than 1 month,” the CDC said. At least one newborn has reportedly died from the infection.
Parechovirus can spread like other common germs, from feces that are later ingested – likely due to poor handwashing – and through droplets sent airborne by coughing or sneezing. It can be transmitted by people both with and without symptoms of the infection.
The microbe can reproduce for 1-3 weeks in the upper respiratory tract and up to 6 months in the gastrointestinal tract, the CDC said.
Kristina Angel Bryant, MD, a pediatric infectious disease specialist at the University of Louisville Hospital, says parechoviruses often cause rashes on the hands and feet, which some experts refer to as “mittens and booties.”
The CDC is urging doctors to test for parechovirus if they recognize these symptoms in infants if there is no other explanation for what might be distressing them.
There is no specific treatment for parechovirus. And with no standard testing system in place, experts are unsure if the number of parechovirus cases is higher in 2022 than in previous years.
The message for parents, Dr. Bryant says, is: Don’t panic. “This is not a new virus.”
“One of the most common symptoms is fever, and in some kids, that is the only symptom,” she says. “Older infants and toddlers may have only cold symptoms, and some kids have no symptoms at all.”
Parents can take the usual steps to protect their child from the viral illness, including diligent handwashing and having less contact with people who are sick, Dr. Bryant says.
A version of this article first appeared on Medscape.com.
FDA approves topical ruxolitinib for nonsegmental vitiligo
The on July 18. The treatment, which was approved for treating mild to moderate atopic dermatitis in September 2021, is a cream formulation of ruxolitinib, a Janus kinase 1 (JAK1)/JAK2 inhibitor.
Previously, no treatment was approved to repigment patients with vitiligo, says David Rosmarin, MD, vice chair for research and education in the department of dermatology at Tufts Medical Center, Boston. “It’s important to have options that we can give to patients that are both safe and effective to get them the desired results,” Dr. Rosmarin, the lead investigator of the phase 3 clinical trials of topical ruxolitinib, said in an interview. Vitiligo is “a disease that can really affect quality of life. Some people [with vitiligo] feel as if they’re being stared at or they’re being bullied; they don’t feel confident. It can affect relationships and intimacy.”
Approval was based on the results of two phase 3 trials (TruE-V1 and TruE-V2) in 674 patients with nonsegmental vitiligo aged 12 years or older. At 24 weeks, about 30% of the patients on treatment, applied twice a day, achieved at least a 75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75), compared with about 8% and 13% among those in the vehicle groups in the two trials.
At 52 weeks, about 50% of the patients treated with topical ruxolitinib achieved F-VASI75.
Also, using self-reporting as measured by the Vitiligo Noticeability Scale, about 30%-40% of patients described their vitiligo as being “a lot less noticeable” or “no longer noticeable” at week 52. Dr. Rosmarin reported the 52-week results at the 2022 annual meeting of the American Academy of Dermatology.
The trial group used 1.5% ruxolitinib cream twice daily for the full year. The vehicle group began using ruxolitinib halfway through the trial. In this group, 26.8% and 29.6% achieved F-VASI 75 at 52 weeks in the two trials.
For treating vitiligo, patients are advised to apply a thin layer of topical ruxolitinib to affected areas twice a day, “up to 10% body surface area,” according to the prescribing information, which adds: “Satisfactory patient response may require treatment … for more than 24 weeks. If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be reevaluated by the health care provider.”
The most common side effects during the vehicle-controlled part of the trials were development of acne and pruritus at the application site, headache, urinary tract infections, erythema at the application site, and pyrexia, according to the company.
The approved label for topical ruxolitinib includes a boxed warning about serious infections, mortality, cancer, major adverse cardiovascular events, and thrombosis – which, the warning notes, is based on reports in patients treated with oral JAK inhibitors for inflammatory conditions.
Dr. Rosmarin believes that using this drug with other therapies, like light treatment, might yield even better responses. The available data are in patients treated with ruxolitinib as monotherapy, without complementary therapies.
William Damsky, MD, PhD, professor of dermatology and dermatopathology at Yale University, New Haven, who was not involved in the trials, said what is most exciting about this drug is its novelty. Although some topical steroids are used off-label to treat vitiligo, their efficacy is far from what’s been observed in these trials of topical ruxolitinib, he told this news organization. “It’s huge for a number of reasons. … One very big reason is it just provides some hope” for the many patients with vitiligo who, over the years, have been told “that there’s nothing that could be done for their disease, and this really changes that.”
Dr. Rosmarin reports financial relationships with over 20 pharmaceutical companies. Dr. Damsky disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The on July 18. The treatment, which was approved for treating mild to moderate atopic dermatitis in September 2021, is a cream formulation of ruxolitinib, a Janus kinase 1 (JAK1)/JAK2 inhibitor.
Previously, no treatment was approved to repigment patients with vitiligo, says David Rosmarin, MD, vice chair for research and education in the department of dermatology at Tufts Medical Center, Boston. “It’s important to have options that we can give to patients that are both safe and effective to get them the desired results,” Dr. Rosmarin, the lead investigator of the phase 3 clinical trials of topical ruxolitinib, said in an interview. Vitiligo is “a disease that can really affect quality of life. Some people [with vitiligo] feel as if they’re being stared at or they’re being bullied; they don’t feel confident. It can affect relationships and intimacy.”
Approval was based on the results of two phase 3 trials (TruE-V1 and TruE-V2) in 674 patients with nonsegmental vitiligo aged 12 years or older. At 24 weeks, about 30% of the patients on treatment, applied twice a day, achieved at least a 75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75), compared with about 8% and 13% among those in the vehicle groups in the two trials.
At 52 weeks, about 50% of the patients treated with topical ruxolitinib achieved F-VASI75.
Also, using self-reporting as measured by the Vitiligo Noticeability Scale, about 30%-40% of patients described their vitiligo as being “a lot less noticeable” or “no longer noticeable” at week 52. Dr. Rosmarin reported the 52-week results at the 2022 annual meeting of the American Academy of Dermatology.
The trial group used 1.5% ruxolitinib cream twice daily for the full year. The vehicle group began using ruxolitinib halfway through the trial. In this group, 26.8% and 29.6% achieved F-VASI 75 at 52 weeks in the two trials.
For treating vitiligo, patients are advised to apply a thin layer of topical ruxolitinib to affected areas twice a day, “up to 10% body surface area,” according to the prescribing information, which adds: “Satisfactory patient response may require treatment … for more than 24 weeks. If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be reevaluated by the health care provider.”
The most common side effects during the vehicle-controlled part of the trials were development of acne and pruritus at the application site, headache, urinary tract infections, erythema at the application site, and pyrexia, according to the company.
The approved label for topical ruxolitinib includes a boxed warning about serious infections, mortality, cancer, major adverse cardiovascular events, and thrombosis – which, the warning notes, is based on reports in patients treated with oral JAK inhibitors for inflammatory conditions.
Dr. Rosmarin believes that using this drug with other therapies, like light treatment, might yield even better responses. The available data are in patients treated with ruxolitinib as monotherapy, without complementary therapies.
William Damsky, MD, PhD, professor of dermatology and dermatopathology at Yale University, New Haven, who was not involved in the trials, said what is most exciting about this drug is its novelty. Although some topical steroids are used off-label to treat vitiligo, their efficacy is far from what’s been observed in these trials of topical ruxolitinib, he told this news organization. “It’s huge for a number of reasons. … One very big reason is it just provides some hope” for the many patients with vitiligo who, over the years, have been told “that there’s nothing that could be done for their disease, and this really changes that.”
Dr. Rosmarin reports financial relationships with over 20 pharmaceutical companies. Dr. Damsky disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The on July 18. The treatment, which was approved for treating mild to moderate atopic dermatitis in September 2021, is a cream formulation of ruxolitinib, a Janus kinase 1 (JAK1)/JAK2 inhibitor.
Previously, no treatment was approved to repigment patients with vitiligo, says David Rosmarin, MD, vice chair for research and education in the department of dermatology at Tufts Medical Center, Boston. “It’s important to have options that we can give to patients that are both safe and effective to get them the desired results,” Dr. Rosmarin, the lead investigator of the phase 3 clinical trials of topical ruxolitinib, said in an interview. Vitiligo is “a disease that can really affect quality of life. Some people [with vitiligo] feel as if they’re being stared at or they’re being bullied; they don’t feel confident. It can affect relationships and intimacy.”
Approval was based on the results of two phase 3 trials (TruE-V1 and TruE-V2) in 674 patients with nonsegmental vitiligo aged 12 years or older. At 24 weeks, about 30% of the patients on treatment, applied twice a day, achieved at least a 75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75), compared with about 8% and 13% among those in the vehicle groups in the two trials.
At 52 weeks, about 50% of the patients treated with topical ruxolitinib achieved F-VASI75.
Also, using self-reporting as measured by the Vitiligo Noticeability Scale, about 30%-40% of patients described their vitiligo as being “a lot less noticeable” or “no longer noticeable” at week 52. Dr. Rosmarin reported the 52-week results at the 2022 annual meeting of the American Academy of Dermatology.
The trial group used 1.5% ruxolitinib cream twice daily for the full year. The vehicle group began using ruxolitinib halfway through the trial. In this group, 26.8% and 29.6% achieved F-VASI 75 at 52 weeks in the two trials.
For treating vitiligo, patients are advised to apply a thin layer of topical ruxolitinib to affected areas twice a day, “up to 10% body surface area,” according to the prescribing information, which adds: “Satisfactory patient response may require treatment … for more than 24 weeks. If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be reevaluated by the health care provider.”
The most common side effects during the vehicle-controlled part of the trials were development of acne and pruritus at the application site, headache, urinary tract infections, erythema at the application site, and pyrexia, according to the company.
The approved label for topical ruxolitinib includes a boxed warning about serious infections, mortality, cancer, major adverse cardiovascular events, and thrombosis – which, the warning notes, is based on reports in patients treated with oral JAK inhibitors for inflammatory conditions.
Dr. Rosmarin believes that using this drug with other therapies, like light treatment, might yield even better responses. The available data are in patients treated with ruxolitinib as monotherapy, without complementary therapies.
William Damsky, MD, PhD, professor of dermatology and dermatopathology at Yale University, New Haven, who was not involved in the trials, said what is most exciting about this drug is its novelty. Although some topical steroids are used off-label to treat vitiligo, their efficacy is far from what’s been observed in these trials of topical ruxolitinib, he told this news organization. “It’s huge for a number of reasons. … One very big reason is it just provides some hope” for the many patients with vitiligo who, over the years, have been told “that there’s nothing that could be done for their disease, and this really changes that.”
Dr. Rosmarin reports financial relationships with over 20 pharmaceutical companies. Dr. Damsky disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA grants emergency authorization for Novavax COVID vaccine
on July 13.
The vaccine is authorized for adults only. Should the Centers for Disease Control and Prevention follow suit and approve its use, Novavax would join Moderna, Pfizer and Johnson & Johnson on the U.S. market. A CDC panel of advisors is expected to consider the new entry on July 19.
The Novavax vaccine is only for those who have not yet been vaccinated at all.
“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, MD, said in a statement. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”
The Novavax vaccine is protein-based, making it different than mRNA vaccines from Pfizer and Moderna. It contains harmless elements of actual coronavirus spike protein and an ingredient known as a adjuvant that enhances the patient’s immune response.
Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19. Only 17 patients out of 17,200 developed COVID-19 after receiving both doses.
The FDA said, however, that Novavax’s vaccine did show evidence of increased risk of myocarditis – inflammation of the heart – and pericarditis, inflammation of tissue surrounding the heart. In most people both disorders began within 10 days.
A version of this article first appeared on WebMD.com.
on July 13.
The vaccine is authorized for adults only. Should the Centers for Disease Control and Prevention follow suit and approve its use, Novavax would join Moderna, Pfizer and Johnson & Johnson on the U.S. market. A CDC panel of advisors is expected to consider the new entry on July 19.
The Novavax vaccine is only for those who have not yet been vaccinated at all.
“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, MD, said in a statement. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”
The Novavax vaccine is protein-based, making it different than mRNA vaccines from Pfizer and Moderna. It contains harmless elements of actual coronavirus spike protein and an ingredient known as a adjuvant that enhances the patient’s immune response.
Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19. Only 17 patients out of 17,200 developed COVID-19 after receiving both doses.
The FDA said, however, that Novavax’s vaccine did show evidence of increased risk of myocarditis – inflammation of the heart – and pericarditis, inflammation of tissue surrounding the heart. In most people both disorders began within 10 days.
A version of this article first appeared on WebMD.com.
on July 13.
The vaccine is authorized for adults only. Should the Centers for Disease Control and Prevention follow suit and approve its use, Novavax would join Moderna, Pfizer and Johnson & Johnson on the U.S. market. A CDC panel of advisors is expected to consider the new entry on July 19.
The Novavax vaccine is only for those who have not yet been vaccinated at all.
“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, MD, said in a statement. “COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”
The Novavax vaccine is protein-based, making it different than mRNA vaccines from Pfizer and Moderna. It contains harmless elements of actual coronavirus spike protein and an ingredient known as a adjuvant that enhances the patient’s immune response.
Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19. Only 17 patients out of 17,200 developed COVID-19 after receiving both doses.
The FDA said, however, that Novavax’s vaccine did show evidence of increased risk of myocarditis – inflammation of the heart – and pericarditis, inflammation of tissue surrounding the heart. In most people both disorders began within 10 days.
A version of this article first appeared on WebMD.com.
FDA approves combination pegloticase and methotrexate for refractory gout
Pegloticase, which has been available for 12 years, is a pegylated uric acid specific enzyme that lowers sUA by converting it to allantoin.
Though pegloticase is effective in treating chronic gout in patients refractory to conventional treatment, approximately 92% of patients develop antibodies against the drug, resulting in reduced efficacy.
Based on the immunomodulatory effects of methotrexate, researchers of the randomized, placebo-controlled MIRROR trial sought to determine whether combination treatment of pegloticase with methotrexate (multiple brands) would prevent the development of anti-drug antibodies.
Findings from the phase 4 trial found that co-administration of pegloticase and methotrexate reduced the formation of new anti-PEG antibodies. In the group receiving methotrexate and pegloticase, 23.2% (22 out of 95) of patients had an increase in anti-PEG antibodies, compared with 50% (24 of 48) in the pegloticase plus placebo group, according to a recent company press release.
Nearly three-quarters (71%) of participants in the group pretreated with methotrexate, followed by combination pegloticase-methotrexate, had sUA levels that dopped to below 6 mg/dL during the 52-week study. By comparison, 38.5% of participants in the pegloticase and placebo group reached the endpoint. Though gout flare occurred in both groups, methotrexate did not appear to increase the risk for adverse events or gout flare.
The study, led by John Botson, MD, RPh, CCD, a rheumatologist in Anchorage, Alaska, concluded that these measurements demonstrated a significant improvement from traditional pegloticase-only treatment of gout. “This trial confirms not only improved efficacy but improved safety in patients treated with pegloticase in combination with methotrexate 15 mg orally once weekly,” Dr. Botson said last month in an interview with this news organization.
The study was funded by Horizon. Dr. Botson reports receiving research support from Horizon and Radius Health and speaker fees from AbbVie, Amgen, Aurinia, ChemoCentryx, Horizon, Eli Lilly, and Novartis.
A version of this article first appeared on Medscape.com.
Pegloticase, which has been available for 12 years, is a pegylated uric acid specific enzyme that lowers sUA by converting it to allantoin.
Though pegloticase is effective in treating chronic gout in patients refractory to conventional treatment, approximately 92% of patients develop antibodies against the drug, resulting in reduced efficacy.
Based on the immunomodulatory effects of methotrexate, researchers of the randomized, placebo-controlled MIRROR trial sought to determine whether combination treatment of pegloticase with methotrexate (multiple brands) would prevent the development of anti-drug antibodies.
Findings from the phase 4 trial found that co-administration of pegloticase and methotrexate reduced the formation of new anti-PEG antibodies. In the group receiving methotrexate and pegloticase, 23.2% (22 out of 95) of patients had an increase in anti-PEG antibodies, compared with 50% (24 of 48) in the pegloticase plus placebo group, according to a recent company press release.
Nearly three-quarters (71%) of participants in the group pretreated with methotrexate, followed by combination pegloticase-methotrexate, had sUA levels that dopped to below 6 mg/dL during the 52-week study. By comparison, 38.5% of participants in the pegloticase and placebo group reached the endpoint. Though gout flare occurred in both groups, methotrexate did not appear to increase the risk for adverse events or gout flare.
The study, led by John Botson, MD, RPh, CCD, a rheumatologist in Anchorage, Alaska, concluded that these measurements demonstrated a significant improvement from traditional pegloticase-only treatment of gout. “This trial confirms not only improved efficacy but improved safety in patients treated with pegloticase in combination with methotrexate 15 mg orally once weekly,” Dr. Botson said last month in an interview with this news organization.
The study was funded by Horizon. Dr. Botson reports receiving research support from Horizon and Radius Health and speaker fees from AbbVie, Amgen, Aurinia, ChemoCentryx, Horizon, Eli Lilly, and Novartis.
A version of this article first appeared on Medscape.com.
Pegloticase, which has been available for 12 years, is a pegylated uric acid specific enzyme that lowers sUA by converting it to allantoin.
Though pegloticase is effective in treating chronic gout in patients refractory to conventional treatment, approximately 92% of patients develop antibodies against the drug, resulting in reduced efficacy.
Based on the immunomodulatory effects of methotrexate, researchers of the randomized, placebo-controlled MIRROR trial sought to determine whether combination treatment of pegloticase with methotrexate (multiple brands) would prevent the development of anti-drug antibodies.
Findings from the phase 4 trial found that co-administration of pegloticase and methotrexate reduced the formation of new anti-PEG antibodies. In the group receiving methotrexate and pegloticase, 23.2% (22 out of 95) of patients had an increase in anti-PEG antibodies, compared with 50% (24 of 48) in the pegloticase plus placebo group, according to a recent company press release.
Nearly three-quarters (71%) of participants in the group pretreated with methotrexate, followed by combination pegloticase-methotrexate, had sUA levels that dopped to below 6 mg/dL during the 52-week study. By comparison, 38.5% of participants in the pegloticase and placebo group reached the endpoint. Though gout flare occurred in both groups, methotrexate did not appear to increase the risk for adverse events or gout flare.
The study, led by John Botson, MD, RPh, CCD, a rheumatologist in Anchorage, Alaska, concluded that these measurements demonstrated a significant improvement from traditional pegloticase-only treatment of gout. “This trial confirms not only improved efficacy but improved safety in patients treated with pegloticase in combination with methotrexate 15 mg orally once weekly,” Dr. Botson said last month in an interview with this news organization.
The study was funded by Horizon. Dr. Botson reports receiving research support from Horizon and Radius Health and speaker fees from AbbVie, Amgen, Aurinia, ChemoCentryx, Horizon, Eli Lilly, and Novartis.
A version of this article first appeared on Medscape.com.
Neck floats may not be right for certain babies, FDA warns
The FDA is warning that parents should avoid using neck floats for infants with special needs or developmental delays.
According to the agency, companies have been advertising the products as having health benefits for children with physical and developmental problems, despite a lack of evidence for such claims. The companies, which the FDA did not name, claimed that water therapy with floats could help babies with special needs – like those with spina bifida – to increase muscle tone, boost flexibility and range of motion, and build lung capacity, among other benefits.
But used improperly, neck floats can lead to serious injury and death. At least one baby has died, and one was hospitalized, after using the floats, FDA officials said.
The inflatable plastic rings are worn around a baby’s neck, allowing them to float freely in water. Some of these products are being marketed for infants as young as 2 weeks old, as well as for premature babies. But the FDA said the safety and effectiveness of the products for these children have not been proven.
The floats “have not been evaluated by the FDA, and we are not aware of any demonstrated benefit with the use of neck floats for water therapy interventions,” the agency said in the June 28 statement.
While injuries and deaths from neck floats are rare, the FDA said families and caregivers should be aware that these incidents can and do occur.
People who have problems with the neck floats are encouraged to report them through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by the FDA are required to file new reports with the FDA.
A version of this article first appeared on WebMD.com.
The FDA is warning that parents should avoid using neck floats for infants with special needs or developmental delays.
According to the agency, companies have been advertising the products as having health benefits for children with physical and developmental problems, despite a lack of evidence for such claims. The companies, which the FDA did not name, claimed that water therapy with floats could help babies with special needs – like those with spina bifida – to increase muscle tone, boost flexibility and range of motion, and build lung capacity, among other benefits.
But used improperly, neck floats can lead to serious injury and death. At least one baby has died, and one was hospitalized, after using the floats, FDA officials said.
The inflatable plastic rings are worn around a baby’s neck, allowing them to float freely in water. Some of these products are being marketed for infants as young as 2 weeks old, as well as for premature babies. But the FDA said the safety and effectiveness of the products for these children have not been proven.
The floats “have not been evaluated by the FDA, and we are not aware of any demonstrated benefit with the use of neck floats for water therapy interventions,” the agency said in the June 28 statement.
While injuries and deaths from neck floats are rare, the FDA said families and caregivers should be aware that these incidents can and do occur.
People who have problems with the neck floats are encouraged to report them through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by the FDA are required to file new reports with the FDA.
A version of this article first appeared on WebMD.com.
The FDA is warning that parents should avoid using neck floats for infants with special needs or developmental delays.
According to the agency, companies have been advertising the products as having health benefits for children with physical and developmental problems, despite a lack of evidence for such claims. The companies, which the FDA did not name, claimed that water therapy with floats could help babies with special needs – like those with spina bifida – to increase muscle tone, boost flexibility and range of motion, and build lung capacity, among other benefits.
But used improperly, neck floats can lead to serious injury and death. At least one baby has died, and one was hospitalized, after using the floats, FDA officials said.
The inflatable plastic rings are worn around a baby’s neck, allowing them to float freely in water. Some of these products are being marketed for infants as young as 2 weeks old, as well as for premature babies. But the FDA said the safety and effectiveness of the products for these children have not been proven.
The floats “have not been evaluated by the FDA, and we are not aware of any demonstrated benefit with the use of neck floats for water therapy interventions,” the agency said in the June 28 statement.
While injuries and deaths from neck floats are rare, the FDA said families and caregivers should be aware that these incidents can and do occur.
People who have problems with the neck floats are encouraged to report them through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by the FDA are required to file new reports with the FDA.
A version of this article first appeared on WebMD.com.