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Company submits supplemental NDA for topical atopic dermatitis treatment
in adults and children aged 6 years and older.
Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.
According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
in adults and children aged 6 years and older.
Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.
According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
in adults and children aged 6 years and older.
Roflumilast cream 0.3% (Zoryve) is currently approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older. Submission of the sNDA is based on positive results from the Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis (INTEGUMENT-1 and INTEGUMENT-2) trials; two identical Phase 3, vehicle-controlled trials in which roflumilast cream 0.15% or vehicle was applied once daily for 4 weeks to individuals 6 years of age and older with mild to moderate AD involving at least 3% body surface area. Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor.
According to a press release from Arcutis, both studies met the primary endpoint of IGA Success, which was defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 4. In INTEGUMENT-1 this endpoint was achieved by 32.0% of subjects in the roflumilast cream group vs. 15.2% of those in the vehicle group (P < .0001). In INTEGUMENT-2, this endpoint was achieved by 28.9% of subjects in the roflumilast cream group vs. 12.0% of those in the vehicle group (P < .0001). The most common adverse reactions based on data from the combined trials were headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
New COVID vaccines force bivalents out
COVID vaccines will have a new formulation in 2023, according to a decision announced by the U.S. Food and Drug Administration, that will focus efforts on circulating variants. The move pushes last year’s bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.
The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.
The new vaccines are authorized for use in individuals age 6 months and older. And the new options are being developed using a similar process as previous formulations, according to the FDA.
Targeting circulating variants
In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.
“This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants,” according to the report.
Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit-to-risk profile is well understood as they move forward with new formulations.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
Timing the effort
On Sept. 12 the U.S. Centers for Disease Control and Prevention recommended that everyone 6 months and older get an updated COVID-19 vaccine. Updated vaccines from Pfizer-BioNTech and Moderna will be available later this week, according to the agency.
This article was updated 9/14/23.
A version of this article appeared on Medscape.com.
COVID vaccines will have a new formulation in 2023, according to a decision announced by the U.S. Food and Drug Administration, that will focus efforts on circulating variants. The move pushes last year’s bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.
The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.
The new vaccines are authorized for use in individuals age 6 months and older. And the new options are being developed using a similar process as previous formulations, according to the FDA.
Targeting circulating variants
In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.
“This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants,” according to the report.
Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit-to-risk profile is well understood as they move forward with new formulations.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
Timing the effort
On Sept. 12 the U.S. Centers for Disease Control and Prevention recommended that everyone 6 months and older get an updated COVID-19 vaccine. Updated vaccines from Pfizer-BioNTech and Moderna will be available later this week, according to the agency.
This article was updated 9/14/23.
A version of this article appeared on Medscape.com.
COVID vaccines will have a new formulation in 2023, according to a decision announced by the U.S. Food and Drug Administration, that will focus efforts on circulating variants. The move pushes last year’s bivalent vaccines out of circulation because they will no longer be authorized for use in the United States.
The updated mRNA vaccines for 2023-2024 are being revised to include a single component that corresponds to the Omicron variant XBB.1.5. Like the bivalents offered before, the new monovalents are being manufactured by Moderna and Pfizer.
The new vaccines are authorized for use in individuals age 6 months and older. And the new options are being developed using a similar process as previous formulations, according to the FDA.
Targeting circulating variants
In recent studies, regulators point out the extent of neutralization observed by the updated vaccines against currently circulating viral variants causing COVID-19, including EG.5, BA.2.86, appears to be of a similar magnitude to the extent of neutralization observed with previous versions of the vaccines against corresponding prior variants.
“This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants,” according to the report.
Hundreds of millions of people in the United States have already received previously approved mRNA COVID vaccines, according to regulators who say the benefit-to-risk profile is well understood as they move forward with new formulations.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
Timing the effort
On Sept. 12 the U.S. Centers for Disease Control and Prevention recommended that everyone 6 months and older get an updated COVID-19 vaccine. Updated vaccines from Pfizer-BioNTech and Moderna will be available later this week, according to the agency.
This article was updated 9/14/23.
A version of this article appeared on Medscape.com.
FDA approves motixafortide for stem cell mobilization in myeloma
The success of autologous stem cell transplantation (ASCT) depends on adequate mobilization of stem cells during the treatment process. Collection of a sufficient number of stem cells to perform two transplantations is recommended. However, in up to 47% of patients, collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session remains a challenge, BioLineRx explained in a press release today, announcing the approval.
The goal of combining motixafortide with filgrastim is to mobilize stem cells more reliably than filgrastim can alone, with fewer days of apheresis sessions and fewer doses of filgrastim.
“We believe [motixafortide] will play a critical role in addressing unmet needs and introduce a new treatment paradigm for” patients with multiple myeloma, CEO Philip Serlin said in the release.
The drug approval was based on the GENESIS trial, which randomized 122 patients to either motixafortide plus filgrastim or placebo plus filgrastim.
BioLineRx said the trial included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with about 70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.
Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of 6 million or more CD34+ cells/kg within two apheresis sessions, versus 9.5% of patients receiving the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the motixafortide arm and 21.4% in the placebo arm.
However, “the data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted,” the company said.
Serious adverse reactions occurred in 5.4% of patients in the motixafortide arm, including vomiting, injection-site reaction, hypersensitivity reaction, injection-site cellulitis, hypokalemia, and hypoxia. The most common adverse reactions, occurring in more than 20% of patients, were injection site reactions (pain, erythema, and pruritus), pruritus, flushing, and back pain.
Labeling for the subcutaneous injection is available online.
A version of this article first appeared on Medscape.com.
The success of autologous stem cell transplantation (ASCT) depends on adequate mobilization of stem cells during the treatment process. Collection of a sufficient number of stem cells to perform two transplantations is recommended. However, in up to 47% of patients, collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session remains a challenge, BioLineRx explained in a press release today, announcing the approval.
The goal of combining motixafortide with filgrastim is to mobilize stem cells more reliably than filgrastim can alone, with fewer days of apheresis sessions and fewer doses of filgrastim.
“We believe [motixafortide] will play a critical role in addressing unmet needs and introduce a new treatment paradigm for” patients with multiple myeloma, CEO Philip Serlin said in the release.
The drug approval was based on the GENESIS trial, which randomized 122 patients to either motixafortide plus filgrastim or placebo plus filgrastim.
BioLineRx said the trial included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with about 70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.
Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of 6 million or more CD34+ cells/kg within two apheresis sessions, versus 9.5% of patients receiving the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the motixafortide arm and 21.4% in the placebo arm.
However, “the data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted,” the company said.
Serious adverse reactions occurred in 5.4% of patients in the motixafortide arm, including vomiting, injection-site reaction, hypersensitivity reaction, injection-site cellulitis, hypokalemia, and hypoxia. The most common adverse reactions, occurring in more than 20% of patients, were injection site reactions (pain, erythema, and pruritus), pruritus, flushing, and back pain.
Labeling for the subcutaneous injection is available online.
A version of this article first appeared on Medscape.com.
The success of autologous stem cell transplantation (ASCT) depends on adequate mobilization of stem cells during the treatment process. Collection of a sufficient number of stem cells to perform two transplantations is recommended. However, in up to 47% of patients, collecting target numbers of hematopoietic stem cells for ASCT after one apheresis session remains a challenge, BioLineRx explained in a press release today, announcing the approval.
The goal of combining motixafortide with filgrastim is to mobilize stem cells more reliably than filgrastim can alone, with fewer days of apheresis sessions and fewer doses of filgrastim.
“We believe [motixafortide] will play a critical role in addressing unmet needs and introduce a new treatment paradigm for” patients with multiple myeloma, CEO Philip Serlin said in the release.
The drug approval was based on the GENESIS trial, which randomized 122 patients to either motixafortide plus filgrastim or placebo plus filgrastim.
BioLineRx said the trial included patients considered representative of the typical multiple myeloma population undergoing ASCT, with a median age of 63 years and with about 70% of patients in both arms of the trial receiving lenalidomide-containing induction therapy.
Motixafortide plus filgrastim enabled 67.5% of patients to achieve the stem cell collection goal of 6 million or more CD34+ cells/kg within two apheresis sessions, versus 9.5% of patients receiving the placebo plus filgrastim regimen. Additionally, 92.5% of patients reached the stem cell collection goal in up to two apheresis sessions in the motixafortide arm and 21.4% in the placebo arm.
However, “the data are descriptive and were not statistically powered nor prespecified. The information should be cautiously interpreted,” the company said.
Serious adverse reactions occurred in 5.4% of patients in the motixafortide arm, including vomiting, injection-site reaction, hypersensitivity reaction, injection-site cellulitis, hypokalemia, and hypoxia. The most common adverse reactions, occurring in more than 20% of patients, were injection site reactions (pain, erythema, and pruritus), pruritus, flushing, and back pain.
Labeling for the subcutaneous injection is available online.
A version of this article first appeared on Medscape.com.
RSV season has started, and this year could be different
The Centers for Disease Control and Prevention issued a national alert to health officials Sept. 5, urging them to offer new medicines that can prevent severe cases of the respiratory virus in very young children and in older people. Those two groups are at the highest risk of potentially deadly complications from RSV.
Typically, the CDC considers the start of RSV season to occur when the rate of positive tests for the virus goes above 3% for 2 consecutive weeks. In Florida, the rate has been around 5% in recent weeks, and in Georgia, there has been an increase in RSV-related hospitalizations. Most of the hospitalizations in Georgia have been among infants less than a year old.
“Historically, such regional increases have predicted the beginning of RSV season nationally, with increased RSV activity spreading north and west over the following 2-3 months,” the CDC said.
Most children have been infected with RSV by the time they are 2 years old. Historically, up to 80,000 children under 5 years old are hospitalized annually because of the virus, and between 100 and 300 die from complications each year.
Those figures could be drastically different this year because new preventive treatments are available.
The CDC recommends that all children under 8 months old receive the newly approved monoclonal antibody treatment nirsevimab (Beyfortus). Children up to 19 months old at high risk of severe complications from RSV are also eligible for the single-dose shot. In clinical trials, the treatment was 80% effective at preventing RSV infections from becoming so severe that children had to be hospitalized. The protection lasted about 5 months.
Older people are also at a heightened risk of severe illness from RSV, and two new vaccines are available this season. The vaccines are called Arexvy and Abrysvo, and the single-dose shots are approved for people ages 60 years and older. They are more than 80% effective at making severe lower respiratory complications less likely.
Last year’s RSV season started during the summer and peaked in October and November, which was earlier than usual. There’s no indication yet of when RSV season may peak this year. Last year and throughout the pandemic, RSV held its historical pattern of starting in Florida.
A version of this article appeared on WebMD.com.
The Centers for Disease Control and Prevention issued a national alert to health officials Sept. 5, urging them to offer new medicines that can prevent severe cases of the respiratory virus in very young children and in older people. Those two groups are at the highest risk of potentially deadly complications from RSV.
Typically, the CDC considers the start of RSV season to occur when the rate of positive tests for the virus goes above 3% for 2 consecutive weeks. In Florida, the rate has been around 5% in recent weeks, and in Georgia, there has been an increase in RSV-related hospitalizations. Most of the hospitalizations in Georgia have been among infants less than a year old.
“Historically, such regional increases have predicted the beginning of RSV season nationally, with increased RSV activity spreading north and west over the following 2-3 months,” the CDC said.
Most children have been infected with RSV by the time they are 2 years old. Historically, up to 80,000 children under 5 years old are hospitalized annually because of the virus, and between 100 and 300 die from complications each year.
Those figures could be drastically different this year because new preventive treatments are available.
The CDC recommends that all children under 8 months old receive the newly approved monoclonal antibody treatment nirsevimab (Beyfortus). Children up to 19 months old at high risk of severe complications from RSV are also eligible for the single-dose shot. In clinical trials, the treatment was 80% effective at preventing RSV infections from becoming so severe that children had to be hospitalized. The protection lasted about 5 months.
Older people are also at a heightened risk of severe illness from RSV, and two new vaccines are available this season. The vaccines are called Arexvy and Abrysvo, and the single-dose shots are approved for people ages 60 years and older. They are more than 80% effective at making severe lower respiratory complications less likely.
Last year’s RSV season started during the summer and peaked in October and November, which was earlier than usual. There’s no indication yet of when RSV season may peak this year. Last year and throughout the pandemic, RSV held its historical pattern of starting in Florida.
A version of this article appeared on WebMD.com.
The Centers for Disease Control and Prevention issued a national alert to health officials Sept. 5, urging them to offer new medicines that can prevent severe cases of the respiratory virus in very young children and in older people. Those two groups are at the highest risk of potentially deadly complications from RSV.
Typically, the CDC considers the start of RSV season to occur when the rate of positive tests for the virus goes above 3% for 2 consecutive weeks. In Florida, the rate has been around 5% in recent weeks, and in Georgia, there has been an increase in RSV-related hospitalizations. Most of the hospitalizations in Georgia have been among infants less than a year old.
“Historically, such regional increases have predicted the beginning of RSV season nationally, with increased RSV activity spreading north and west over the following 2-3 months,” the CDC said.
Most children have been infected with RSV by the time they are 2 years old. Historically, up to 80,000 children under 5 years old are hospitalized annually because of the virus, and between 100 and 300 die from complications each year.
Those figures could be drastically different this year because new preventive treatments are available.
The CDC recommends that all children under 8 months old receive the newly approved monoclonal antibody treatment nirsevimab (Beyfortus). Children up to 19 months old at high risk of severe complications from RSV are also eligible for the single-dose shot. In clinical trials, the treatment was 80% effective at preventing RSV infections from becoming so severe that children had to be hospitalized. The protection lasted about 5 months.
Older people are also at a heightened risk of severe illness from RSV, and two new vaccines are available this season. The vaccines are called Arexvy and Abrysvo, and the single-dose shots are approved for people ages 60 years and older. They are more than 80% effective at making severe lower respiratory complications less likely.
Last year’s RSV season started during the summer and peaked in October and November, which was earlier than usual. There’s no indication yet of when RSV season may peak this year. Last year and throughout the pandemic, RSV held its historical pattern of starting in Florida.
A version of this article appeared on WebMD.com.
FDA approves canakinumab for gout flares
The U.S. Food and Drug Administration has approved canakinumab (Ilaris) for the treatment of gout flares in adults who cannot be treated with NSAIDs, colchicine, or repeated courses of corticosteroids. The drug is also indicated for people who could not tolerate or had an inadequate response to NSAIDs or colchicine.
The drug, a humanized anti–interleukin-1 beta monoclonal antibody, is the first and only biologic approved in the United States for the treatment of gout flares, according to Novartis. It is administered in a single, subcutaneous injection of 150 mg.
“At Novartis, we are committed to bringing medicines that address high unmet needs to patients. We are proud to receive approval on our eighth indication for Ilaris in the U.S. and provide the first biologic medicine option for people with gout flares to help treat this painful and debilitating condition,” the company said in a statement to this news organization.
Canakinumab was first approved in the United States in 2009 for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS). Since then, it has been approved for the treatment of several other autoinflammatory diseases, including Still’s disease and recurrent fever syndromes.
In 2011, an FDA advisory panel voted against the approval of canakinumab to treat acute gout flares refractory to NSAIDs, colchicine, or repeated courses of corticosteroids, while in 2013, the European Medicine Agency approved the drug for this treatment indication.
Since that FDA advisory committee meeting and the FDA’s subsequent rejection letter, “[Novartis] has conducted additional studies in patients with gout flares and other related populations to further characterize the short- and long-term safety of canakinumab supporting the current application. To further support the benefit-risk [profile of the drug], the indication is for a more restricted population than initially proposed in 2011,” the FDA’s Center for Drug Evaluation and Research said in a statement to this news organization. “Given these considerations and the available safety information, the Agency determined that canakinumab, at the recommended dosage, has a favorable risk-benefit profile” in the specified patient population.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved canakinumab (Ilaris) for the treatment of gout flares in adults who cannot be treated with NSAIDs, colchicine, or repeated courses of corticosteroids. The drug is also indicated for people who could not tolerate or had an inadequate response to NSAIDs or colchicine.
The drug, a humanized anti–interleukin-1 beta monoclonal antibody, is the first and only biologic approved in the United States for the treatment of gout flares, according to Novartis. It is administered in a single, subcutaneous injection of 150 mg.
“At Novartis, we are committed to bringing medicines that address high unmet needs to patients. We are proud to receive approval on our eighth indication for Ilaris in the U.S. and provide the first biologic medicine option for people with gout flares to help treat this painful and debilitating condition,” the company said in a statement to this news organization.
Canakinumab was first approved in the United States in 2009 for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS). Since then, it has been approved for the treatment of several other autoinflammatory diseases, including Still’s disease and recurrent fever syndromes.
In 2011, an FDA advisory panel voted against the approval of canakinumab to treat acute gout flares refractory to NSAIDs, colchicine, or repeated courses of corticosteroids, while in 2013, the European Medicine Agency approved the drug for this treatment indication.
Since that FDA advisory committee meeting and the FDA’s subsequent rejection letter, “[Novartis] has conducted additional studies in patients with gout flares and other related populations to further characterize the short- and long-term safety of canakinumab supporting the current application. To further support the benefit-risk [profile of the drug], the indication is for a more restricted population than initially proposed in 2011,” the FDA’s Center for Drug Evaluation and Research said in a statement to this news organization. “Given these considerations and the available safety information, the Agency determined that canakinumab, at the recommended dosage, has a favorable risk-benefit profile” in the specified patient population.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved canakinumab (Ilaris) for the treatment of gout flares in adults who cannot be treated with NSAIDs, colchicine, or repeated courses of corticosteroids. The drug is also indicated for people who could not tolerate or had an inadequate response to NSAIDs or colchicine.
The drug, a humanized anti–interleukin-1 beta monoclonal antibody, is the first and only biologic approved in the United States for the treatment of gout flares, according to Novartis. It is administered in a single, subcutaneous injection of 150 mg.
“At Novartis, we are committed to bringing medicines that address high unmet needs to patients. We are proud to receive approval on our eighth indication for Ilaris in the U.S. and provide the first biologic medicine option for people with gout flares to help treat this painful and debilitating condition,” the company said in a statement to this news organization.
Canakinumab was first approved in the United States in 2009 for the treatment of children and adults with cryopyrin-associated periodic syndrome (CAPS). Since then, it has been approved for the treatment of several other autoinflammatory diseases, including Still’s disease and recurrent fever syndromes.
In 2011, an FDA advisory panel voted against the approval of canakinumab to treat acute gout flares refractory to NSAIDs, colchicine, or repeated courses of corticosteroids, while in 2013, the European Medicine Agency approved the drug for this treatment indication.
Since that FDA advisory committee meeting and the FDA’s subsequent rejection letter, “[Novartis] has conducted additional studies in patients with gout flares and other related populations to further characterize the short- and long-term safety of canakinumab supporting the current application. To further support the benefit-risk [profile of the drug], the indication is for a more restricted population than initially proposed in 2011,” the FDA’s Center for Drug Evaluation and Research said in a statement to this news organization. “Given these considerations and the available safety information, the Agency determined that canakinumab, at the recommended dosage, has a favorable risk-benefit profile” in the specified patient population.
A version of this article first appeared on Medscape.com.
FDA okays first biosimilar for multiple sclerosis
including clinically isolated syndrome, relapsing remitting MS, and active secondary progressive disease.
“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis. [This] approval could have a meaningful impact for patients managing their disease,” Paul R. Lee, MD, PhD, director of the division of neurology II, FDA Center for Drug Evaluation and Research, said in a statement.
The natalizumab biosimilar is given using the same dosing and administration schedule. Like the reference product, it is indicated for adults with moderately to severely active Crohn’s disease unresponsive to other medications.
The approval of the natalizumab biosimilar is based on results of the phase 3 Antelope trial, which showed no clinically meaningful differences between it and the reference product.
The trial included 264 adults (mean age, 36 years; 61% women) with relapsing remitting MS from 48 centers in seven Eastern European countries.
All were randomly assigned to receive intravenous infusions every 4 weeks of 300 mg of the natalizumab biosimilar or the reference product for a total of 12 infusions.
At 24 and 48 weeks, there were no between-group differences in annualized relapse rates or Expanded Disability Status Scale scores, which were similar between treatment groups at baseline. There were also no significant differences in safety, tolerability, or immunogenicity.
The prescribing information for both natalizumab products includes a boxed warning about the increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to death or severe disability.
Risk factors for the development of PML include the presence of antibodies to the JC virus, longer duration of therapy, and prior use of immunosuppressants.
“These factors should be considered in the context of expected benefit when initiating and continuing treatment with natalizumab products, and health care providers should monitor patients and withhold treatment immediately at the first sign or symptom suggestive of PML,” the FDA advises.
Because of the risks of PML, natalizumab products are available only through a restricted drug distribution program under a risk evaluation and mitigation strategy.
In a statement, Sandoz said it’s committed to having the product available in the United States “as soon as possible.”
A version of this article appeared on Medscape.com.
including clinically isolated syndrome, relapsing remitting MS, and active secondary progressive disease.
“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis. [This] approval could have a meaningful impact for patients managing their disease,” Paul R. Lee, MD, PhD, director of the division of neurology II, FDA Center for Drug Evaluation and Research, said in a statement.
The natalizumab biosimilar is given using the same dosing and administration schedule. Like the reference product, it is indicated for adults with moderately to severely active Crohn’s disease unresponsive to other medications.
The approval of the natalizumab biosimilar is based on results of the phase 3 Antelope trial, which showed no clinically meaningful differences between it and the reference product.
The trial included 264 adults (mean age, 36 years; 61% women) with relapsing remitting MS from 48 centers in seven Eastern European countries.
All were randomly assigned to receive intravenous infusions every 4 weeks of 300 mg of the natalizumab biosimilar or the reference product for a total of 12 infusions.
At 24 and 48 weeks, there were no between-group differences in annualized relapse rates or Expanded Disability Status Scale scores, which were similar between treatment groups at baseline. There were also no significant differences in safety, tolerability, or immunogenicity.
The prescribing information for both natalizumab products includes a boxed warning about the increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to death or severe disability.
Risk factors for the development of PML include the presence of antibodies to the JC virus, longer duration of therapy, and prior use of immunosuppressants.
“These factors should be considered in the context of expected benefit when initiating and continuing treatment with natalizumab products, and health care providers should monitor patients and withhold treatment immediately at the first sign or symptom suggestive of PML,” the FDA advises.
Because of the risks of PML, natalizumab products are available only through a restricted drug distribution program under a risk evaluation and mitigation strategy.
In a statement, Sandoz said it’s committed to having the product available in the United States “as soon as possible.”
A version of this article appeared on Medscape.com.
including clinically isolated syndrome, relapsing remitting MS, and active secondary progressive disease.
“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis. [This] approval could have a meaningful impact for patients managing their disease,” Paul R. Lee, MD, PhD, director of the division of neurology II, FDA Center for Drug Evaluation and Research, said in a statement.
The natalizumab biosimilar is given using the same dosing and administration schedule. Like the reference product, it is indicated for adults with moderately to severely active Crohn’s disease unresponsive to other medications.
The approval of the natalizumab biosimilar is based on results of the phase 3 Antelope trial, which showed no clinically meaningful differences between it and the reference product.
The trial included 264 adults (mean age, 36 years; 61% women) with relapsing remitting MS from 48 centers in seven Eastern European countries.
All were randomly assigned to receive intravenous infusions every 4 weeks of 300 mg of the natalizumab biosimilar or the reference product for a total of 12 infusions.
At 24 and 48 weeks, there were no between-group differences in annualized relapse rates or Expanded Disability Status Scale scores, which were similar between treatment groups at baseline. There were also no significant differences in safety, tolerability, or immunogenicity.
The prescribing information for both natalizumab products includes a boxed warning about the increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to death or severe disability.
Risk factors for the development of PML include the presence of antibodies to the JC virus, longer duration of therapy, and prior use of immunosuppressants.
“These factors should be considered in the context of expected benefit when initiating and continuing treatment with natalizumab products, and health care providers should monitor patients and withhold treatment immediately at the first sign or symptom suggestive of PML,” the FDA advises.
Because of the risks of PML, natalizumab products are available only through a restricted drug distribution program under a risk evaluation and mitigation strategy.
In a statement, Sandoz said it’s committed to having the product available in the United States “as soon as possible.”
A version of this article appeared on Medscape.com.
One in five women report mistreatment during maternity care
“We have to do better at providing respectful and unbiased care to all mothers,” Debra E. Houry, MD, chief medical officer of the Centers for Disease Control and Prevention, said in a press briefing announcing the findings, which were published as a Vital Signs report in the CDC’s Morbidity and Mortality Weekly Report.
Previous research showed an increase in maternal deaths in the United States from 17.4 to 32.9 per 100,000 live births between 2018 and 2021, but approximately 80% of these deaths are preventable, wrote Yousra A. Mohamoud, PhD, of the CDC’s division of reproductive health, and colleagues.
“Maternal mortality review committees have identified discrimination as one factor contributing to pregnancy-related deaths,” the researchers wrote. Respectful care must be part of a larger strategy to prevent these deaths, they emphasized.
In the report, researchers reviewed data from 2,402 women who responded to an opt-in survey. The survey was conducted for the CDC through Porter Novelli, and no personally identifying information was included. Nearly 70% of the participants were White, 10.7% were Black, 10.2% were Hispanic, 4.8% were Asian, 1.5% were American Indian, Alaska Native, Pacific Islander, or Native Hawaiian, 2.8% were multiracial, and 0.5% were another race.
The survey included questions about maternity care experiences during pregnancy and delivery of the youngest child. For 65.5% of respondents, their youngest child was 5 years or older at the time of the survey.
Mistreatment during maternity care was defined using seven validated questions, including questions about violations of physical privacy, verbal abuse, and inattention to requests for help. Satisfaction with maternity care was defined as “very satisfied” or “somewhat satisfied.”
Participants also responded to questions about discrimination during maternity care based on factors such as race, ethnicity, skin color, age, and weight. Finally, participants were asked whether they refrained from asking questions about their health or raising concerns with health care providers.
Overall, 20.4% of respondents reported experiencing one of the defined forms of mistreatment during maternity care. The most common mistreatment reported by the women was being ignored by providers when they requested help (9.7%), followed by being shouted at or scolded (6.7%), having physical privacy violated (5.1%), and being forced to accept unwanted treatment or threatened with withholding of treatment (4.6%).
However, approximately 90% of women overall and 75% of those who reported any mistreatment were very or somewhat satisfied with their maternity care.
When stratified by race, mistreatment was reported most frequently by Black, Hispanic, and multiracial women (30%, 29%, and 27%, respectively).
Overall, 29% of women reported experiencing some type of discrimination; the most frequently reported reasons were age, weight, and income. Black women reported the highest rates of discrimination (40%) followed by multiracial women (39%) and Hispanic women (37%).
With regard to self-advocacy, 45% of women reported holding back from asking questions of health care providers; the most common reasons were thinking their health concerns were normal for pregnancy, being embarrassed, and being concerned that health care providers would consider them difficult.
In addition, more women with no insurance or public insurance at the time of delivery reported mistreatment during their maternity care than did women with private insurance (28%, 26%, and 16%, respectively).
The findings were limited by several factors, including the opt-in nature of the survey, which means that the data are likely not representative of the birthing population in the United States, the researchers noted. Other limitations included the reliance on self-reports, potential recall bias, use of English language only, and use of a combined category for respondents of American Indian, Alaska Native, Native Hawaiian, and Pacific Islander ethnicity.
However, the results highlight the need for improving respectful care as part of a larger strategy to reduce pregnancy-related deaths, the researchers said. At the system level, quality improvement programs are needed to standardize care and support providers in recognizing and reducing biases and increasing cultural awareness and communication. At the provider level, clinicians at all points in the maternity care process can improve patient experiences by providing equitable and respectful care, and by listening to and addressing patients’ concerns.
In addition, communication campaigns and community engagement can include perspectives of patients, families, and communities to support women and encourage them to ask questions and express concerns, the researchers said.
Improving respectful care can be part of actions to reduce mortality at all levels, the researchers noted. The Hear Her campaign, developed by the CDC Foundation with funding from Merck, provides resources for pregnant and postpartum women and their support networks to help reduce pregnancy-related deaths and complications by encouraging women to share concerns with providers and to recognize urgent maternal warning signs.
The study received no outside funding. The researchers had no financial conflicts to disclose.
“We have to do better at providing respectful and unbiased care to all mothers,” Debra E. Houry, MD, chief medical officer of the Centers for Disease Control and Prevention, said in a press briefing announcing the findings, which were published as a Vital Signs report in the CDC’s Morbidity and Mortality Weekly Report.
Previous research showed an increase in maternal deaths in the United States from 17.4 to 32.9 per 100,000 live births between 2018 and 2021, but approximately 80% of these deaths are preventable, wrote Yousra A. Mohamoud, PhD, of the CDC’s division of reproductive health, and colleagues.
“Maternal mortality review committees have identified discrimination as one factor contributing to pregnancy-related deaths,” the researchers wrote. Respectful care must be part of a larger strategy to prevent these deaths, they emphasized.
In the report, researchers reviewed data from 2,402 women who responded to an opt-in survey. The survey was conducted for the CDC through Porter Novelli, and no personally identifying information was included. Nearly 70% of the participants were White, 10.7% were Black, 10.2% were Hispanic, 4.8% were Asian, 1.5% were American Indian, Alaska Native, Pacific Islander, or Native Hawaiian, 2.8% were multiracial, and 0.5% were another race.
The survey included questions about maternity care experiences during pregnancy and delivery of the youngest child. For 65.5% of respondents, their youngest child was 5 years or older at the time of the survey.
Mistreatment during maternity care was defined using seven validated questions, including questions about violations of physical privacy, verbal abuse, and inattention to requests for help. Satisfaction with maternity care was defined as “very satisfied” or “somewhat satisfied.”
Participants also responded to questions about discrimination during maternity care based on factors such as race, ethnicity, skin color, age, and weight. Finally, participants were asked whether they refrained from asking questions about their health or raising concerns with health care providers.
Overall, 20.4% of respondents reported experiencing one of the defined forms of mistreatment during maternity care. The most common mistreatment reported by the women was being ignored by providers when they requested help (9.7%), followed by being shouted at or scolded (6.7%), having physical privacy violated (5.1%), and being forced to accept unwanted treatment or threatened with withholding of treatment (4.6%).
However, approximately 90% of women overall and 75% of those who reported any mistreatment were very or somewhat satisfied with their maternity care.
When stratified by race, mistreatment was reported most frequently by Black, Hispanic, and multiracial women (30%, 29%, and 27%, respectively).
Overall, 29% of women reported experiencing some type of discrimination; the most frequently reported reasons were age, weight, and income. Black women reported the highest rates of discrimination (40%) followed by multiracial women (39%) and Hispanic women (37%).
With regard to self-advocacy, 45% of women reported holding back from asking questions of health care providers; the most common reasons were thinking their health concerns were normal for pregnancy, being embarrassed, and being concerned that health care providers would consider them difficult.
In addition, more women with no insurance or public insurance at the time of delivery reported mistreatment during their maternity care than did women with private insurance (28%, 26%, and 16%, respectively).
The findings were limited by several factors, including the opt-in nature of the survey, which means that the data are likely not representative of the birthing population in the United States, the researchers noted. Other limitations included the reliance on self-reports, potential recall bias, use of English language only, and use of a combined category for respondents of American Indian, Alaska Native, Native Hawaiian, and Pacific Islander ethnicity.
However, the results highlight the need for improving respectful care as part of a larger strategy to reduce pregnancy-related deaths, the researchers said. At the system level, quality improvement programs are needed to standardize care and support providers in recognizing and reducing biases and increasing cultural awareness and communication. At the provider level, clinicians at all points in the maternity care process can improve patient experiences by providing equitable and respectful care, and by listening to and addressing patients’ concerns.
In addition, communication campaigns and community engagement can include perspectives of patients, families, and communities to support women and encourage them to ask questions and express concerns, the researchers said.
Improving respectful care can be part of actions to reduce mortality at all levels, the researchers noted. The Hear Her campaign, developed by the CDC Foundation with funding from Merck, provides resources for pregnant and postpartum women and their support networks to help reduce pregnancy-related deaths and complications by encouraging women to share concerns with providers and to recognize urgent maternal warning signs.
The study received no outside funding. The researchers had no financial conflicts to disclose.
“We have to do better at providing respectful and unbiased care to all mothers,” Debra E. Houry, MD, chief medical officer of the Centers for Disease Control and Prevention, said in a press briefing announcing the findings, which were published as a Vital Signs report in the CDC’s Morbidity and Mortality Weekly Report.
Previous research showed an increase in maternal deaths in the United States from 17.4 to 32.9 per 100,000 live births between 2018 and 2021, but approximately 80% of these deaths are preventable, wrote Yousra A. Mohamoud, PhD, of the CDC’s division of reproductive health, and colleagues.
“Maternal mortality review committees have identified discrimination as one factor contributing to pregnancy-related deaths,” the researchers wrote. Respectful care must be part of a larger strategy to prevent these deaths, they emphasized.
In the report, researchers reviewed data from 2,402 women who responded to an opt-in survey. The survey was conducted for the CDC through Porter Novelli, and no personally identifying information was included. Nearly 70% of the participants were White, 10.7% were Black, 10.2% were Hispanic, 4.8% were Asian, 1.5% were American Indian, Alaska Native, Pacific Islander, or Native Hawaiian, 2.8% were multiracial, and 0.5% were another race.
The survey included questions about maternity care experiences during pregnancy and delivery of the youngest child. For 65.5% of respondents, their youngest child was 5 years or older at the time of the survey.
Mistreatment during maternity care was defined using seven validated questions, including questions about violations of physical privacy, verbal abuse, and inattention to requests for help. Satisfaction with maternity care was defined as “very satisfied” or “somewhat satisfied.”
Participants also responded to questions about discrimination during maternity care based on factors such as race, ethnicity, skin color, age, and weight. Finally, participants were asked whether they refrained from asking questions about their health or raising concerns with health care providers.
Overall, 20.4% of respondents reported experiencing one of the defined forms of mistreatment during maternity care. The most common mistreatment reported by the women was being ignored by providers when they requested help (9.7%), followed by being shouted at or scolded (6.7%), having physical privacy violated (5.1%), and being forced to accept unwanted treatment or threatened with withholding of treatment (4.6%).
However, approximately 90% of women overall and 75% of those who reported any mistreatment were very or somewhat satisfied with their maternity care.
When stratified by race, mistreatment was reported most frequently by Black, Hispanic, and multiracial women (30%, 29%, and 27%, respectively).
Overall, 29% of women reported experiencing some type of discrimination; the most frequently reported reasons were age, weight, and income. Black women reported the highest rates of discrimination (40%) followed by multiracial women (39%) and Hispanic women (37%).
With regard to self-advocacy, 45% of women reported holding back from asking questions of health care providers; the most common reasons were thinking their health concerns were normal for pregnancy, being embarrassed, and being concerned that health care providers would consider them difficult.
In addition, more women with no insurance or public insurance at the time of delivery reported mistreatment during their maternity care than did women with private insurance (28%, 26%, and 16%, respectively).
The findings were limited by several factors, including the opt-in nature of the survey, which means that the data are likely not representative of the birthing population in the United States, the researchers noted. Other limitations included the reliance on self-reports, potential recall bias, use of English language only, and use of a combined category for respondents of American Indian, Alaska Native, Native Hawaiian, and Pacific Islander ethnicity.
However, the results highlight the need for improving respectful care as part of a larger strategy to reduce pregnancy-related deaths, the researchers said. At the system level, quality improvement programs are needed to standardize care and support providers in recognizing and reducing biases and increasing cultural awareness and communication. At the provider level, clinicians at all points in the maternity care process can improve patient experiences by providing equitable and respectful care, and by listening to and addressing patients’ concerns.
In addition, communication campaigns and community engagement can include perspectives of patients, families, and communities to support women and encourage them to ask questions and express concerns, the researchers said.
Improving respectful care can be part of actions to reduce mortality at all levels, the researchers noted. The Hear Her campaign, developed by the CDC Foundation with funding from Merck, provides resources for pregnant and postpartum women and their support networks to help reduce pregnancy-related deaths and complications by encouraging women to share concerns with providers and to recognize urgent maternal warning signs.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM MMWR
CDC tracking new COVID strain
On Aug. 17, the agency posted on X, formerly known as Twitter, that the lineage has been detected in the United States, Denmark, and Israel.
“As we learn more about BA.2.86, CDC’s advice on protecting yourself from COVID-19 remains the same,” the CDC said on X.
A case of BA.2.86 was detected at a laboratory at the University of Michigan, CBS News reported. It’s not clear how the university obtained the sample that was sequenced. A case was also detected in the United Kingdom, the news outlet said.
The World Health Organization is also tracking BA.2.86 and has classified it as a “variant under monitoring.”
“More data are needed to understand this COVID-19 variant and the extent of its spread, but the number of mutations warrants attention. WHO will update countries and the public as we learn more,” the WHO said on X.
The strain is so new that scientists don’t know if BA.2.86 is more easily spread, causes more severe symptoms than existing strains, or will be more resistant to vaccines and natural immunity developed over the last few years.
Early research indicates BA.2.86 “will have equal or greater escape than XBB.1.5 from antibodies elicited by pre-Omicron and first-generation Omicron variants,” Jesse Bloom, PhD, a virologist at the Fred Hutchinson Cancer Center, said in a slide deck published Aug. 17. (XBB.1.5 is the Omicron subvariant that is targeted in the updated COVID booster shot to be released soon.)
Still, Dr. Bloom noted that “even if a highly mutated new variant like BA.2.86 starts to spread, we will be in a far better place than we were in 2020 and 2021, since most people have some immunity to SARS-CoV-2 now.”
A version of this article first appeared on WebMD.com.
On Aug. 17, the agency posted on X, formerly known as Twitter, that the lineage has been detected in the United States, Denmark, and Israel.
“As we learn more about BA.2.86, CDC’s advice on protecting yourself from COVID-19 remains the same,” the CDC said on X.
A case of BA.2.86 was detected at a laboratory at the University of Michigan, CBS News reported. It’s not clear how the university obtained the sample that was sequenced. A case was also detected in the United Kingdom, the news outlet said.
The World Health Organization is also tracking BA.2.86 and has classified it as a “variant under monitoring.”
“More data are needed to understand this COVID-19 variant and the extent of its spread, but the number of mutations warrants attention. WHO will update countries and the public as we learn more,” the WHO said on X.
The strain is so new that scientists don’t know if BA.2.86 is more easily spread, causes more severe symptoms than existing strains, or will be more resistant to vaccines and natural immunity developed over the last few years.
Early research indicates BA.2.86 “will have equal or greater escape than XBB.1.5 from antibodies elicited by pre-Omicron and first-generation Omicron variants,” Jesse Bloom, PhD, a virologist at the Fred Hutchinson Cancer Center, said in a slide deck published Aug. 17. (XBB.1.5 is the Omicron subvariant that is targeted in the updated COVID booster shot to be released soon.)
Still, Dr. Bloom noted that “even if a highly mutated new variant like BA.2.86 starts to spread, we will be in a far better place than we were in 2020 and 2021, since most people have some immunity to SARS-CoV-2 now.”
A version of this article first appeared on WebMD.com.
On Aug. 17, the agency posted on X, formerly known as Twitter, that the lineage has been detected in the United States, Denmark, and Israel.
“As we learn more about BA.2.86, CDC’s advice on protecting yourself from COVID-19 remains the same,” the CDC said on X.
A case of BA.2.86 was detected at a laboratory at the University of Michigan, CBS News reported. It’s not clear how the university obtained the sample that was sequenced. A case was also detected in the United Kingdom, the news outlet said.
The World Health Organization is also tracking BA.2.86 and has classified it as a “variant under monitoring.”
“More data are needed to understand this COVID-19 variant and the extent of its spread, but the number of mutations warrants attention. WHO will update countries and the public as we learn more,” the WHO said on X.
The strain is so new that scientists don’t know if BA.2.86 is more easily spread, causes more severe symptoms than existing strains, or will be more resistant to vaccines and natural immunity developed over the last few years.
Early research indicates BA.2.86 “will have equal or greater escape than XBB.1.5 from antibodies elicited by pre-Omicron and first-generation Omicron variants,” Jesse Bloom, PhD, a virologist at the Fred Hutchinson Cancer Center, said in a slide deck published Aug. 17. (XBB.1.5 is the Omicron subvariant that is targeted in the updated COVID booster shot to be released soon.)
Still, Dr. Bloom noted that “even if a highly mutated new variant like BA.2.86 starts to spread, we will be in a far better place than we were in 2020 and 2021, since most people have some immunity to SARS-CoV-2 now.”
A version of this article first appeared on WebMD.com.
Patient safety vs. public health: The ethylene oxide dilemma
Ethylene oxide is a compound used to sterilize more than 20 billion devices sold in the U.S. every year. Although this sterilization process helps keep medical devices – and patients – safe, the odorless, flammable gas may also be harming people who live near sterilization plants and who may inhale the compound, which has been linked to an elevated risk of cancer.
Lawmakers are weighing in on the matter, which has been the source of multiple civil lawsuits filed by individuals who say they have suffered health problems as a result of exposure to ethylene oxide.
The Environmental Protection Agency and the U.S. Food and Drug Administration agree that use of the compound should be limited, but they are at odds about how quickly limits should be put in place, according to Axios.
A new commercial standard for ethylene oxide proposed by the EPA in April would impose stricter emission restrictions for sterilization facilities and chemical plants – a move that would cut ethylene oxide emissions by 80%, the EPA estimates.
While the FDA says it “shares concerns about the release of ethylene oxide at unsafe levels into the environment,” the agency cautions that moving too fast to cut emissions would disrupt the medical supply chain, which is already experiencing turbulence. The U.S. has been facing the worst drug supply shortages in a decade in addition to severe medical device shortages.
Currently, other methods of sterilization cannot replace the use of ethylene oxide for many devices. Ethylene oxide is used to sterilize about half of all medical devices in the U.S., the FDA says. Given the country’s reliance on this compound for sterilization, the FDA says it is “equally concerned about the potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations.”
In 2019, Illinois temporarily closed a sterilization facility over concern regarding ethylene oxide emissions. The closure caused a shortage of a pediatric breathing tube.
Some lawmakers agree that an Interior-Environment bill would require FDA certification that any action by the EPA would not cause a medical device shortage.
The FDA has been working to identify safe alternatives to ethylene oxide for sterilizing medical supplies as well as strategies to reduce emissions of ethylene oxide by capturing the gas or by turning it into a harmless byproduct. In 2019, the FDA launched a pilot program to incentivize companies to develop new sterilization technologies.
“The FDA remains focused in our commitment to encourage novel ways to sterilize medical devices while reducing adverse impacts on the environment and public health and developing solutions to avoid potential shortages of devices that the American public relies upon,” the agency said.
A version of this article first appeared on Medscape.com.
Ethylene oxide is a compound used to sterilize more than 20 billion devices sold in the U.S. every year. Although this sterilization process helps keep medical devices – and patients – safe, the odorless, flammable gas may also be harming people who live near sterilization plants and who may inhale the compound, which has been linked to an elevated risk of cancer.
Lawmakers are weighing in on the matter, which has been the source of multiple civil lawsuits filed by individuals who say they have suffered health problems as a result of exposure to ethylene oxide.
The Environmental Protection Agency and the U.S. Food and Drug Administration agree that use of the compound should be limited, but they are at odds about how quickly limits should be put in place, according to Axios.
A new commercial standard for ethylene oxide proposed by the EPA in April would impose stricter emission restrictions for sterilization facilities and chemical plants – a move that would cut ethylene oxide emissions by 80%, the EPA estimates.
While the FDA says it “shares concerns about the release of ethylene oxide at unsafe levels into the environment,” the agency cautions that moving too fast to cut emissions would disrupt the medical supply chain, which is already experiencing turbulence. The U.S. has been facing the worst drug supply shortages in a decade in addition to severe medical device shortages.
Currently, other methods of sterilization cannot replace the use of ethylene oxide for many devices. Ethylene oxide is used to sterilize about half of all medical devices in the U.S., the FDA says. Given the country’s reliance on this compound for sterilization, the FDA says it is “equally concerned about the potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations.”
In 2019, Illinois temporarily closed a sterilization facility over concern regarding ethylene oxide emissions. The closure caused a shortage of a pediatric breathing tube.
Some lawmakers agree that an Interior-Environment bill would require FDA certification that any action by the EPA would not cause a medical device shortage.
The FDA has been working to identify safe alternatives to ethylene oxide for sterilizing medical supplies as well as strategies to reduce emissions of ethylene oxide by capturing the gas or by turning it into a harmless byproduct. In 2019, the FDA launched a pilot program to incentivize companies to develop new sterilization technologies.
“The FDA remains focused in our commitment to encourage novel ways to sterilize medical devices while reducing adverse impacts on the environment and public health and developing solutions to avoid potential shortages of devices that the American public relies upon,” the agency said.
A version of this article first appeared on Medscape.com.
Ethylene oxide is a compound used to sterilize more than 20 billion devices sold in the U.S. every year. Although this sterilization process helps keep medical devices – and patients – safe, the odorless, flammable gas may also be harming people who live near sterilization plants and who may inhale the compound, which has been linked to an elevated risk of cancer.
Lawmakers are weighing in on the matter, which has been the source of multiple civil lawsuits filed by individuals who say they have suffered health problems as a result of exposure to ethylene oxide.
The Environmental Protection Agency and the U.S. Food and Drug Administration agree that use of the compound should be limited, but they are at odds about how quickly limits should be put in place, according to Axios.
A new commercial standard for ethylene oxide proposed by the EPA in April would impose stricter emission restrictions for sterilization facilities and chemical plants – a move that would cut ethylene oxide emissions by 80%, the EPA estimates.
While the FDA says it “shares concerns about the release of ethylene oxide at unsafe levels into the environment,” the agency cautions that moving too fast to cut emissions would disrupt the medical supply chain, which is already experiencing turbulence. The U.S. has been facing the worst drug supply shortages in a decade in addition to severe medical device shortages.
Currently, other methods of sterilization cannot replace the use of ethylene oxide for many devices. Ethylene oxide is used to sterilize about half of all medical devices in the U.S., the FDA says. Given the country’s reliance on this compound for sterilization, the FDA says it is “equally concerned about the potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations.”
In 2019, Illinois temporarily closed a sterilization facility over concern regarding ethylene oxide emissions. The closure caused a shortage of a pediatric breathing tube.
Some lawmakers agree that an Interior-Environment bill would require FDA certification that any action by the EPA would not cause a medical device shortage.
The FDA has been working to identify safe alternatives to ethylene oxide for sterilizing medical supplies as well as strategies to reduce emissions of ethylene oxide by capturing the gas or by turning it into a harmless byproduct. In 2019, the FDA launched a pilot program to incentivize companies to develop new sterilization technologies.
“The FDA remains focused in our commitment to encourage novel ways to sterilize medical devices while reducing adverse impacts on the environment and public health and developing solutions to avoid potential shortages of devices that the American public relies upon,” the agency said.
A version of this article first appeared on Medscape.com.
West Nile infections rising in the U.S.
Several signs are pointing to an impending surge in the number of human cases of West Nile virus in several regions of the United States.
West Nile virus is spread by infected mosquitoes and currently there is no cure or virus-specific treatment. In rare cases, it can be deadly. It can infect humans, birds, horses, and other mammals.
West Nile Virus is the leading cause of mosquito-borne disease in the continental United States. As of Aug. 8, 126 human cases had been identified across 22 states, according to the Centers for Disease Control and Prevention.
“Particularly here in California, it’s peak risk right now,” said Vicki Kramer, PhD, chief of vector-borne diseases in the California Department of Public Health. She said scientists there are seeing higher mosquito and infected mosquito numbers.
“Peak risk right now”
Dead birds are tested for the virus and by Aug. 4, 181 of the 913 birds tested in California have been positive, three times the total testing positive by this time in 2022.
“Last year at this time, we had 60 positive dead birds out of 817 tested,” Dr. Kramer said.
Severe flooding and high heat can contribute to the rise in mosquito populations and many parts of the country have seen plenty of both.
One of the ways scientists track infected mosquito patterns in California is by using flocks of strategically placed sentinel chickens.
“Chickens are a mosquito magnet,” Dr. Kramer said.
Chickens don’t get sick with the virus, but they do build antibodies to it. Surveillance teams check their blood every other week to track the virus.
Daniel Pastula, MD, MHS, chief of neuroinfectious diseases and global neurology at the University of Colorado School of Medicine and the Colorado School of Public Health, said the state is watching troubling signs as well.
“The concern this year,” Dr. Pastula said, “particularly along the Front Range in Colorado, is we’ve found many more mosquitoes [that are] positive for West Nile earlier in the season compared with other years.
“We’re bracing for higher-than-baseline human cases,” he said.
Asked about this year’s first human case, reported in Toronto, a region with a long winter and low incidence of the virus, he said that provides a further example that people need to be prepared even in climates not known to be mosquito-dense.
He added, however, that climate is only one factor in the severity of the season. Others include birds’ immunity and migratory patterns.
Dr. Pastula said that fluctuations in temperature and rainfall are rising with climate change and are disrupting normal baseline levels of West Nile.
“That shows we need to be prepared for West Nile virus and other mosquito-borne diseases in any place in North America or really the world. We recently saw malaria cases in the southern United States. It just shows you how dangerous mosquitoes can be.”
Avoid mosquito bites
Dr. Pastula and Dr. Kramer list the precautions people can take to protect themselves from West Nile virus:
- Limit outdoor exposure particularly at dusk and dawn.
- Wear protective clothing.
- Use .
- Repair window screens so mosquitoes cannot fly through.
- Dump and drain standing water on your property and maintain swimming pools.
Dr. Pastula noted that summer is the time human cases start to mount – typically from July and August to the first hard freeze.
“We have been warning people here up and down the Front Range of Colorado to take prevention very seriously,” Dr. Pastula said.
He pointed out that 80% who are infected with West Nile will have no symptoms.
About 20% will have flu-like illness – high fever, body and joint aches, rash, diarrhea, or headaches. Symptoms may last for weeks. About 1% of the time, he said, people can get neuroinvasive West Nile.
Dr. Pastula explained that the virus can infect the covering of the brain and spinal cord causing meningitis with very high fever, severe headaches, stiff neck, and sensitivity to light.
So far this year, there have been 89 neuroinvasive cases reported nationally, according to the CDC.
With West Nile encephalitis, the virus “can infect the brain itself causing altered mental status, movement disorders, or weakness,” Dr. Pastula said.
Sometimes it can infect the gray matter of the spinal cord causing a West Nile virus poliomyelitis, which brings polio-like symptoms.
“The West Nile encephalitis and poliomyelitis can cause permanent deficits or even death,” he said. “It’s uncommon but it’s not trivial.”
Several vaccine candidates are in development, Dr. Pastula said, but none has reached clinical trials. Part of the reason for that, he said, is that scientists must be able to predict the timing of an outbreak.
“We’re not really great at predicting outbreaks,” he said.
Although the risk for neuroinvasive disease is small, it can be higher in certain groups, he said – those who are over age 60 years or are immunocompromised; those who have diabetes, cancer, or kidney disease; or those who have undergone organ transplants.
Those infected should see a health care professional and may be able to get relief with the usual medications for flu-like illness.
Some with severe infection may need to go to the hospital, Dr. Pastula said.
A version of this article first appeared on Medscape.com.
Several signs are pointing to an impending surge in the number of human cases of West Nile virus in several regions of the United States.
West Nile virus is spread by infected mosquitoes and currently there is no cure or virus-specific treatment. In rare cases, it can be deadly. It can infect humans, birds, horses, and other mammals.
West Nile Virus is the leading cause of mosquito-borne disease in the continental United States. As of Aug. 8, 126 human cases had been identified across 22 states, according to the Centers for Disease Control and Prevention.
“Particularly here in California, it’s peak risk right now,” said Vicki Kramer, PhD, chief of vector-borne diseases in the California Department of Public Health. She said scientists there are seeing higher mosquito and infected mosquito numbers.
“Peak risk right now”
Dead birds are tested for the virus and by Aug. 4, 181 of the 913 birds tested in California have been positive, three times the total testing positive by this time in 2022.
“Last year at this time, we had 60 positive dead birds out of 817 tested,” Dr. Kramer said.
Severe flooding and high heat can contribute to the rise in mosquito populations and many parts of the country have seen plenty of both.
One of the ways scientists track infected mosquito patterns in California is by using flocks of strategically placed sentinel chickens.
“Chickens are a mosquito magnet,” Dr. Kramer said.
Chickens don’t get sick with the virus, but they do build antibodies to it. Surveillance teams check their blood every other week to track the virus.
Daniel Pastula, MD, MHS, chief of neuroinfectious diseases and global neurology at the University of Colorado School of Medicine and the Colorado School of Public Health, said the state is watching troubling signs as well.
“The concern this year,” Dr. Pastula said, “particularly along the Front Range in Colorado, is we’ve found many more mosquitoes [that are] positive for West Nile earlier in the season compared with other years.
“We’re bracing for higher-than-baseline human cases,” he said.
Asked about this year’s first human case, reported in Toronto, a region with a long winter and low incidence of the virus, he said that provides a further example that people need to be prepared even in climates not known to be mosquito-dense.
He added, however, that climate is only one factor in the severity of the season. Others include birds’ immunity and migratory patterns.
Dr. Pastula said that fluctuations in temperature and rainfall are rising with climate change and are disrupting normal baseline levels of West Nile.
“That shows we need to be prepared for West Nile virus and other mosquito-borne diseases in any place in North America or really the world. We recently saw malaria cases in the southern United States. It just shows you how dangerous mosquitoes can be.”
Avoid mosquito bites
Dr. Pastula and Dr. Kramer list the precautions people can take to protect themselves from West Nile virus:
- Limit outdoor exposure particularly at dusk and dawn.
- Wear protective clothing.
- Use .
- Repair window screens so mosquitoes cannot fly through.
- Dump and drain standing water on your property and maintain swimming pools.
Dr. Pastula noted that summer is the time human cases start to mount – typically from July and August to the first hard freeze.
“We have been warning people here up and down the Front Range of Colorado to take prevention very seriously,” Dr. Pastula said.
He pointed out that 80% who are infected with West Nile will have no symptoms.
About 20% will have flu-like illness – high fever, body and joint aches, rash, diarrhea, or headaches. Symptoms may last for weeks. About 1% of the time, he said, people can get neuroinvasive West Nile.
Dr. Pastula explained that the virus can infect the covering of the brain and spinal cord causing meningitis with very high fever, severe headaches, stiff neck, and sensitivity to light.
So far this year, there have been 89 neuroinvasive cases reported nationally, according to the CDC.
With West Nile encephalitis, the virus “can infect the brain itself causing altered mental status, movement disorders, or weakness,” Dr. Pastula said.
Sometimes it can infect the gray matter of the spinal cord causing a West Nile virus poliomyelitis, which brings polio-like symptoms.
“The West Nile encephalitis and poliomyelitis can cause permanent deficits or even death,” he said. “It’s uncommon but it’s not trivial.”
Several vaccine candidates are in development, Dr. Pastula said, but none has reached clinical trials. Part of the reason for that, he said, is that scientists must be able to predict the timing of an outbreak.
“We’re not really great at predicting outbreaks,” he said.
Although the risk for neuroinvasive disease is small, it can be higher in certain groups, he said – those who are over age 60 years or are immunocompromised; those who have diabetes, cancer, or kidney disease; or those who have undergone organ transplants.
Those infected should see a health care professional and may be able to get relief with the usual medications for flu-like illness.
Some with severe infection may need to go to the hospital, Dr. Pastula said.
A version of this article first appeared on Medscape.com.
Several signs are pointing to an impending surge in the number of human cases of West Nile virus in several regions of the United States.
West Nile virus is spread by infected mosquitoes and currently there is no cure or virus-specific treatment. In rare cases, it can be deadly. It can infect humans, birds, horses, and other mammals.
West Nile Virus is the leading cause of mosquito-borne disease in the continental United States. As of Aug. 8, 126 human cases had been identified across 22 states, according to the Centers for Disease Control and Prevention.
“Particularly here in California, it’s peak risk right now,” said Vicki Kramer, PhD, chief of vector-borne diseases in the California Department of Public Health. She said scientists there are seeing higher mosquito and infected mosquito numbers.
“Peak risk right now”
Dead birds are tested for the virus and by Aug. 4, 181 of the 913 birds tested in California have been positive, three times the total testing positive by this time in 2022.
“Last year at this time, we had 60 positive dead birds out of 817 tested,” Dr. Kramer said.
Severe flooding and high heat can contribute to the rise in mosquito populations and many parts of the country have seen plenty of both.
One of the ways scientists track infected mosquito patterns in California is by using flocks of strategically placed sentinel chickens.
“Chickens are a mosquito magnet,” Dr. Kramer said.
Chickens don’t get sick with the virus, but they do build antibodies to it. Surveillance teams check their blood every other week to track the virus.
Daniel Pastula, MD, MHS, chief of neuroinfectious diseases and global neurology at the University of Colorado School of Medicine and the Colorado School of Public Health, said the state is watching troubling signs as well.
“The concern this year,” Dr. Pastula said, “particularly along the Front Range in Colorado, is we’ve found many more mosquitoes [that are] positive for West Nile earlier in the season compared with other years.
“We’re bracing for higher-than-baseline human cases,” he said.
Asked about this year’s first human case, reported in Toronto, a region with a long winter and low incidence of the virus, he said that provides a further example that people need to be prepared even in climates not known to be mosquito-dense.
He added, however, that climate is only one factor in the severity of the season. Others include birds’ immunity and migratory patterns.
Dr. Pastula said that fluctuations in temperature and rainfall are rising with climate change and are disrupting normal baseline levels of West Nile.
“That shows we need to be prepared for West Nile virus and other mosquito-borne diseases in any place in North America or really the world. We recently saw malaria cases in the southern United States. It just shows you how dangerous mosquitoes can be.”
Avoid mosquito bites
Dr. Pastula and Dr. Kramer list the precautions people can take to protect themselves from West Nile virus:
- Limit outdoor exposure particularly at dusk and dawn.
- Wear protective clothing.
- Use .
- Repair window screens so mosquitoes cannot fly through.
- Dump and drain standing water on your property and maintain swimming pools.
Dr. Pastula noted that summer is the time human cases start to mount – typically from July and August to the first hard freeze.
“We have been warning people here up and down the Front Range of Colorado to take prevention very seriously,” Dr. Pastula said.
He pointed out that 80% who are infected with West Nile will have no symptoms.
About 20% will have flu-like illness – high fever, body and joint aches, rash, diarrhea, or headaches. Symptoms may last for weeks. About 1% of the time, he said, people can get neuroinvasive West Nile.
Dr. Pastula explained that the virus can infect the covering of the brain and spinal cord causing meningitis with very high fever, severe headaches, stiff neck, and sensitivity to light.
So far this year, there have been 89 neuroinvasive cases reported nationally, according to the CDC.
With West Nile encephalitis, the virus “can infect the brain itself causing altered mental status, movement disorders, or weakness,” Dr. Pastula said.
Sometimes it can infect the gray matter of the spinal cord causing a West Nile virus poliomyelitis, which brings polio-like symptoms.
“The West Nile encephalitis and poliomyelitis can cause permanent deficits or even death,” he said. “It’s uncommon but it’s not trivial.”
Several vaccine candidates are in development, Dr. Pastula said, but none has reached clinical trials. Part of the reason for that, he said, is that scientists must be able to predict the timing of an outbreak.
“We’re not really great at predicting outbreaks,” he said.
Although the risk for neuroinvasive disease is small, it can be higher in certain groups, he said – those who are over age 60 years or are immunocompromised; those who have diabetes, cancer, or kidney disease; or those who have undergone organ transplants.
Those infected should see a health care professional and may be able to get relief with the usual medications for flu-like illness.
Some with severe infection may need to go to the hospital, Dr. Pastula said.
A version of this article first appeared on Medscape.com.