News from the FDA/CDC

The U.S. Food and Drug Administration on May 22 approved a new autoinjection option for adalimumab-adbm (Cyltezo), a biosimilar to AbbVie’s adalimumab (Humira), ahead of Cyltezo’s commercial launch on July 1, 2023.

Cyltezo was approved by the FDA in 2017 as a prefilled syringe and was the first biosimilar deemed to be interchangeable with Humira in 2021. It is indicated to treat multiple chronic inflammatory conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa. This new design, which features one-button, three-step activation, has been certified as an “Ease of Use” product by the Arthritis Foundation, Boehringer Ingelheim said in a press release. The 40-mg, prefilled Cyltezo Pen will be available in two-, four-, and six-pack options.

“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, the executive director and biosimilar commercial lead at Boehringer Ingelheim in a statement; “we’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1.”

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration on May 22 approved a new autoinjection option for adalimumab-adbm (Cyltezo), a biosimilar to AbbVie’s adalimumab (Humira), ahead of Cyltezo’s commercial launch on July 1, 2023.

Cyltezo was approved by the FDA in 2017 as a prefilled syringe and was the first biosimilar deemed to be interchangeable with Humira in 2021. It is indicated to treat multiple chronic inflammatory conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa. This new design, which features one-button, three-step activation, has been certified as an “Ease of Use” product by the Arthritis Foundation, Boehringer Ingelheim said in a press release. The 40-mg, prefilled Cyltezo Pen will be available in two-, four-, and six-pack options.

“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, the executive director and biosimilar commercial lead at Boehringer Ingelheim in a statement; “we’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1.”

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration on May 22 approved a new autoinjection option for adalimumab-adbm (Cyltezo), a biosimilar to AbbVie’s adalimumab (Humira), ahead of Cyltezo’s commercial launch on July 1, 2023.

Cyltezo was approved by the FDA in 2017 as a prefilled syringe and was the first biosimilar deemed to be interchangeable with Humira in 2021. It is indicated to treat multiple chronic inflammatory conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa. This new design, which features one-button, three-step activation, has been certified as an “Ease of Use” product by the Arthritis Foundation, Boehringer Ingelheim said in a press release. The 40-mg, prefilled Cyltezo Pen will be available in two-, four-, and six-pack options.

“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, the executive director and biosimilar commercial lead at Boehringer Ingelheim in a statement; “we’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee has voted against the accelerated approval of Intercept Pharmaceuticals’ obeticholic acid (OCA) for treatment of nonalcoholic steatohepatitis (NASH) with stage 2 or 3 fibrosis.

This is the second time that Intercept has sought FDA approval for OCA in treating NASH.

The committee voted 12 to 2 (with 2 abstentions) that the benefits of OCA did not outweigh the risks to this patient population. While OCA showed a modest benefit of improving fibrosis in NASH patients, safety concerns included increased risk for drug-induced liver injury (DILI), cholelithiasis, pruritus, dyslipidemia, and dysglycemia.

Committee members were most concerned with the increased risk for DILI in patients taking OCA. Intercept said that frequent monitoring for DILI in such a large eligible population – an estimated 6-8 million individuals taking the drug to treat the condition – would be difficult.

“Typically, in clinical practice, NASH patients are followed every 6-12 months, so more frequent monitoring would be a substantial change and may not be achievable outside of the clinical trial setting,” according to a briefing document released before the committee meeting.

The FDA estimates that 16.8 million U.S. adults have NASH, with 5.7 million having NASH with advanced fibrosis, according to briefing documents. NASH is the second leading cause of liver transplants in the United States and is the leading cause in women. There are currently no FDA-approved therapies to treat NASH.

OCA, sold under the commercial name Ocaliva, was first approved in 2016 to treat primary biliary cholangitis, and is prescribed at up to 10 mg per day. Intercept proposed that OCA be given in daily 25-mg doses in the treatment of precirrhotic fibrosis attributable to NASH.

In 2019, Intercept initially filed for a new drug application (NDA) for OCA for the treatment of precirrhotic fibrosis attributable to NASH but were issued a Complete Response Letter after the FDA determined that the medication had an “unfavorable risk benefit-risk assessment.” Intercept resubmitted an NDA for OCA in December 2022, including two 18-month analyses from a phase 3 study, REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment). In the study, which included data from 931 patients, OCA 25 mg outperformed placebo in improving fibrosis with no worsening of NASH over 18 months, one of two primary endpoints of the clinical trial. The estimated risk difference ranged from 8.6 to 12.8 across different analyses, which the FDA categorized as a “modest treatment effect.”  

There was no significant difference between OCA 25 mg and placebo in NASH resolution with no worsening fibrosis. Both endpoints were surrogate endpoints, meaning that they were “reasonably likely to predict clinical benefit.” The FDA noted that it is not known if a decrease in fibrosis stage would lead to clinically meaningful outcomes, such as reduction in liver-related events.

The committee members voted 15-1 to defer approval until clinical outcome data is submitted and reviewed. The FDA has set a target decision date regarding the accelerated approval of OCA for NASH for June 22, 2023.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee has voted against the accelerated approval of Intercept Pharmaceuticals’ obeticholic acid (OCA) for treatment of nonalcoholic steatohepatitis (NASH) with stage 2 or 3 fibrosis.

This is the second time that Intercept has sought FDA approval for OCA in treating NASH.

The committee voted 12 to 2 (with 2 abstentions) that the benefits of OCA did not outweigh the risks to this patient population. While OCA showed a modest benefit of improving fibrosis in NASH patients, safety concerns included increased risk for drug-induced liver injury (DILI), cholelithiasis, pruritus, dyslipidemia, and dysglycemia.

Committee members were most concerned with the increased risk for DILI in patients taking OCA. Intercept said that frequent monitoring for DILI in such a large eligible population – an estimated 6-8 million individuals taking the drug to treat the condition – would be difficult.

“Typically, in clinical practice, NASH patients are followed every 6-12 months, so more frequent monitoring would be a substantial change and may not be achievable outside of the clinical trial setting,” according to a briefing document released before the committee meeting.

The FDA estimates that 16.8 million U.S. adults have NASH, with 5.7 million having NASH with advanced fibrosis, according to briefing documents. NASH is the second leading cause of liver transplants in the United States and is the leading cause in women. There are currently no FDA-approved therapies to treat NASH.

OCA, sold under the commercial name Ocaliva, was first approved in 2016 to treat primary biliary cholangitis, and is prescribed at up to 10 mg per day. Intercept proposed that OCA be given in daily 25-mg doses in the treatment of precirrhotic fibrosis attributable to NASH.

In 2019, Intercept initially filed for a new drug application (NDA) for OCA for the treatment of precirrhotic fibrosis attributable to NASH but were issued a Complete Response Letter after the FDA determined that the medication had an “unfavorable risk benefit-risk assessment.” Intercept resubmitted an NDA for OCA in December 2022, including two 18-month analyses from a phase 3 study, REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment). In the study, which included data from 931 patients, OCA 25 mg outperformed placebo in improving fibrosis with no worsening of NASH over 18 months, one of two primary endpoints of the clinical trial. The estimated risk difference ranged from 8.6 to 12.8 across different analyses, which the FDA categorized as a “modest treatment effect.”  

There was no significant difference between OCA 25 mg and placebo in NASH resolution with no worsening fibrosis. Both endpoints were surrogate endpoints, meaning that they were “reasonably likely to predict clinical benefit.” The FDA noted that it is not known if a decrease in fibrosis stage would lead to clinically meaningful outcomes, such as reduction in liver-related events.

The committee members voted 15-1 to defer approval until clinical outcome data is submitted and reviewed. The FDA has set a target decision date regarding the accelerated approval of OCA for NASH for June 22, 2023.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee has voted against the accelerated approval of Intercept Pharmaceuticals’ obeticholic acid (OCA) for treatment of nonalcoholic steatohepatitis (NASH) with stage 2 or 3 fibrosis.

This is the second time that Intercept has sought FDA approval for OCA in treating NASH.

The committee voted 12 to 2 (with 2 abstentions) that the benefits of OCA did not outweigh the risks to this patient population. While OCA showed a modest benefit of improving fibrosis in NASH patients, safety concerns included increased risk for drug-induced liver injury (DILI), cholelithiasis, pruritus, dyslipidemia, and dysglycemia.

Committee members were most concerned with the increased risk for DILI in patients taking OCA. Intercept said that frequent monitoring for DILI in such a large eligible population – an estimated 6-8 million individuals taking the drug to treat the condition – would be difficult.

“Typically, in clinical practice, NASH patients are followed every 6-12 months, so more frequent monitoring would be a substantial change and may not be achievable outside of the clinical trial setting,” according to a briefing document released before the committee meeting.

The FDA estimates that 16.8 million U.S. adults have NASH, with 5.7 million having NASH with advanced fibrosis, according to briefing documents. NASH is the second leading cause of liver transplants in the United States and is the leading cause in women. There are currently no FDA-approved therapies to treat NASH.

OCA, sold under the commercial name Ocaliva, was first approved in 2016 to treat primary biliary cholangitis, and is prescribed at up to 10 mg per day. Intercept proposed that OCA be given in daily 25-mg doses in the treatment of precirrhotic fibrosis attributable to NASH.

In 2019, Intercept initially filed for a new drug application (NDA) for OCA for the treatment of precirrhotic fibrosis attributable to NASH but were issued a Complete Response Letter after the FDA determined that the medication had an “unfavorable risk benefit-risk assessment.” Intercept resubmitted an NDA for OCA in December 2022, including two 18-month analyses from a phase 3 study, REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment). In the study, which included data from 931 patients, OCA 25 mg outperformed placebo in improving fibrosis with no worsening of NASH over 18 months, one of two primary endpoints of the clinical trial. The estimated risk difference ranged from 8.6 to 12.8 across different analyses, which the FDA categorized as a “modest treatment effect.”  

There was no significant difference between OCA 25 mg and placebo in NASH resolution with no worsening fibrosis. Both endpoints were surrogate endpoints, meaning that they were “reasonably likely to predict clinical benefit.” The FDA noted that it is not known if a decrease in fibrosis stage would lead to clinically meaningful outcomes, such as reduction in liver-related events.

The committee members voted 15-1 to defer approval until clinical outcome data is submitted and reviewed. The FDA has set a target decision date regarding the accelerated approval of OCA for NASH for June 22, 2023.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved the first-ever topical gene therapy, which will be used to treat wounds in patients 6 months of age and older who have either recessive or dominant dystrophic epidermolysis bullosa (DEB), a rare skin disease.

Olivier Le Moal/Getty Images

The therapy, Vyjuvek (beremagene geperpavec, formerly known as B-VEC), uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure.

Vyjuvek, developed by Krystal Biotech, is designed to be used repetitively to heal a single wound or on more than one wound. In the pivotal study, the gene therapy, delivered in a topical gel, was administered once a week for 6 months.

The FDA gave Vyjuvek priority review, approving the therapy just 9 months after Krystal filed its application for approval. Vyjuvek is also an orphan drug, giving it potentially 7 years of marketing exclusivity.

“Vyjuvek is the first FDA-approved gene therapy treatment for DEB, a rare and serious genetic skin disorder,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA’s statement  announcing the approval.

“With the FDA approval of Vyjuvek, the DEB population has reached a monumental milestone in the treatment of this horrible disorder,” said Brett Kopelan, executive director of debra of America, a national advocacy group for people with DEB, in a statement issued by Krystal Biotech. “Our hopes have now been realized for a safe and effective treatment for one of the most devastating symptoms of the disorder,” said Mr. Kopelan.

“This is a devastating disease,” said M. Peter Marinkovich, MD, primary investigator of Krystal’s pivotal GEM-3 trial and director of the Blistering Disease Clinic at Stanford Health Care, in the statement issued by Krystal. “Until now, doctors and nurses had no way to stop blisters and wounds from developing on dystrophic EB patient skin, and all we could do was to give them bandages and helplessly watch as new blisters formed,” said Dr. Marinkovich, who is also associate professor of dermatology at Stanford (Calif.) University School of Medicine.

“Because it’s safe and easy to apply directly to wounds, it doesn’t require a lot of supporting technology or specialized expertise, making Vyjuvek highly accessible even to patients who live far away from specialized centers,” he said.

Paras P. Vakharia, MD, PharmD, assistant professor of dermatology at Northwestern University, Chicago, said that Vyjuvek is an important advance for DEB. “This to me would be a treatment that I would consider for almost all patients,” Dr. Vakharia said in an interview.

Dr. Vakharia, who was not involved with trials of Vyjuvek, said he had concerns about whether patients might develop antibodies to either HSV or C7 but that the greater initial worry is if Vyjuvek will be affordable and accessible. “I envision that it will be a costly medication,” he said.

Mr. Kopelan, the patient advocate, said that his organization “will continue to work closely with Krystal to assure patients have ready access to Vyjuvek.”

Krystal did not respond before press time to a request for comment on pricing.

Dystrophic epidermolysis bullosa affects 1 to 3 people per million in the United States. It is caused by mutations in the COL7A1 gene, which encodes the alpha-1 chain of collagen type VII (C7) protein. C7 forms the anchoring fibrils that attach the epidermis to the underlying dermal connective tissue. COL71A mutations that lead to defective, decreased, or absent C7 can make the skin so fragile that it tears with the slightest touch.

DEB usually presents at birth and is divided into two major types depending on the inheritance pattern: recessive dystrophic epidermolysis bullosa and dominant dystrophic epidermolysis bullosa.

People with the dominant form typically have mild cases with blistering primarily on the hands, feet, knees, and elbows. The recessive form can be painful and debilitating, causing widespread blistering. Depending on the severity, it can lead to nonhealing wounds, fusing of fingers and toes, anemia, weak bones, and esophageal and genitourinary strictures. Squamous cell cancers are a frequent cause of death.

Vyjuvek is mixed into an inactive gel and is evenly applied to a wound once a week by a health care professional, according to the FDA.  

The agency recommends the following precautions for patients and caregivers:

• Avoid direct contact with treated wounds and dressings of treated wounds for 24 hours following application. Clean any area that is accidentally exposed.
• Wash hands and wear protective gloves when changing wound dressings.
• Disinfect the bandages used for the first dressing with a viricidal agent, such as 70% isopropyl alcohol, 6% hydrogen peroxide, or less than 0.4% ammonium chloride, and dispose of them in a separate, sealed plastic bag in household waste. Subsequent used dressings and cleaning materials should be disposed of in sealed plastic bags in household waste.

FDA approval of Vyjuvek was based on a randomized, double-blinded, placebo-controlled, 31-patient, phase 3 trial published in the New England Journal of Medicine, which showed that 71% of wounds treated with the gene therapy had complete healing at 3 months, compared with 20% of those treated with placebo (95% confidence interval, 29-73; P < .001). At 6 months, 67% of wounds treated with the gene therapy had complete healing, compared with 22% of wounds treated with placebo (95% CI, 24-68; P = .002).

Almost two-thirds of the patients had at least one adverse event. Most were mild or moderate. The most common events were pruritus, chills, and squamous cell carcinoma, reported in three patients each. SCC cases occurred at wound sites that had not been exposed to Vyjuvek or placebo. Serious adverse events, which were unrelated to the treatment, occurred in three patients and included diarrhea, anemia, and cellulitis.

Krystal will also be seeking marketing approval for Vyjuvek in the European Union, likely in 2024, said the company. In September, the European Medicines Agency’s Pediatric Committee issued a positive opinion on the gene therapy and Krystal’s plan to test B-VEC in children.

Dr. Marinkovich and Dr. Vakharia have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved the first-ever topical gene therapy, which will be used to treat wounds in patients 6 months of age and older who have either recessive or dominant dystrophic epidermolysis bullosa (DEB), a rare skin disease.

Olivier Le Moal/Getty Images

The therapy, Vyjuvek (beremagene geperpavec, formerly known as B-VEC), uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure.

Vyjuvek, developed by Krystal Biotech, is designed to be used repetitively to heal a single wound or on more than one wound. In the pivotal study, the gene therapy, delivered in a topical gel, was administered once a week for 6 months.

The FDA gave Vyjuvek priority review, approving the therapy just 9 months after Krystal filed its application for approval. Vyjuvek is also an orphan drug, giving it potentially 7 years of marketing exclusivity.

“Vyjuvek is the first FDA-approved gene therapy treatment for DEB, a rare and serious genetic skin disorder,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA’s statement  announcing the approval.

“With the FDA approval of Vyjuvek, the DEB population has reached a monumental milestone in the treatment of this horrible disorder,” said Brett Kopelan, executive director of debra of America, a national advocacy group for people with DEB, in a statement issued by Krystal Biotech. “Our hopes have now been realized for a safe and effective treatment for one of the most devastating symptoms of the disorder,” said Mr. Kopelan.

“This is a devastating disease,” said M. Peter Marinkovich, MD, primary investigator of Krystal’s pivotal GEM-3 trial and director of the Blistering Disease Clinic at Stanford Health Care, in the statement issued by Krystal. “Until now, doctors and nurses had no way to stop blisters and wounds from developing on dystrophic EB patient skin, and all we could do was to give them bandages and helplessly watch as new blisters formed,” said Dr. Marinkovich, who is also associate professor of dermatology at Stanford (Calif.) University School of Medicine.

“Because it’s safe and easy to apply directly to wounds, it doesn’t require a lot of supporting technology or specialized expertise, making Vyjuvek highly accessible even to patients who live far away from specialized centers,” he said.

Paras P. Vakharia, MD, PharmD, assistant professor of dermatology at Northwestern University, Chicago, said that Vyjuvek is an important advance for DEB. “This to me would be a treatment that I would consider for almost all patients,” Dr. Vakharia said in an interview.

Dr. Vakharia, who was not involved with trials of Vyjuvek, said he had concerns about whether patients might develop antibodies to either HSV or C7 but that the greater initial worry is if Vyjuvek will be affordable and accessible. “I envision that it will be a costly medication,” he said.

Mr. Kopelan, the patient advocate, said that his organization “will continue to work closely with Krystal to assure patients have ready access to Vyjuvek.”

Krystal did not respond before press time to a request for comment on pricing.

Dystrophic epidermolysis bullosa affects 1 to 3 people per million in the United States. It is caused by mutations in the COL7A1 gene, which encodes the alpha-1 chain of collagen type VII (C7) protein. C7 forms the anchoring fibrils that attach the epidermis to the underlying dermal connective tissue. COL71A mutations that lead to defective, decreased, or absent C7 can make the skin so fragile that it tears with the slightest touch.

DEB usually presents at birth and is divided into two major types depending on the inheritance pattern: recessive dystrophic epidermolysis bullosa and dominant dystrophic epidermolysis bullosa.

People with the dominant form typically have mild cases with blistering primarily on the hands, feet, knees, and elbows. The recessive form can be painful and debilitating, causing widespread blistering. Depending on the severity, it can lead to nonhealing wounds, fusing of fingers and toes, anemia, weak bones, and esophageal and genitourinary strictures. Squamous cell cancers are a frequent cause of death.

Vyjuvek is mixed into an inactive gel and is evenly applied to a wound once a week by a health care professional, according to the FDA.  

The agency recommends the following precautions for patients and caregivers:

• Avoid direct contact with treated wounds and dressings of treated wounds for 24 hours following application. Clean any area that is accidentally exposed.
• Wash hands and wear protective gloves when changing wound dressings.
• Disinfect the bandages used for the first dressing with a viricidal agent, such as 70% isopropyl alcohol, 6% hydrogen peroxide, or less than 0.4% ammonium chloride, and dispose of them in a separate, sealed plastic bag in household waste. Subsequent used dressings and cleaning materials should be disposed of in sealed plastic bags in household waste.

FDA approval of Vyjuvek was based on a randomized, double-blinded, placebo-controlled, 31-patient, phase 3 trial published in the New England Journal of Medicine, which showed that 71% of wounds treated with the gene therapy had complete healing at 3 months, compared with 20% of those treated with placebo (95% confidence interval, 29-73; P < .001). At 6 months, 67% of wounds treated with the gene therapy had complete healing, compared with 22% of wounds treated with placebo (95% CI, 24-68; P = .002).

Almost two-thirds of the patients had at least one adverse event. Most were mild or moderate. The most common events were pruritus, chills, and squamous cell carcinoma, reported in three patients each. SCC cases occurred at wound sites that had not been exposed to Vyjuvek or placebo. Serious adverse events, which were unrelated to the treatment, occurred in three patients and included diarrhea, anemia, and cellulitis.

Krystal will also be seeking marketing approval for Vyjuvek in the European Union, likely in 2024, said the company. In September, the European Medicines Agency’s Pediatric Committee issued a positive opinion on the gene therapy and Krystal’s plan to test B-VEC in children.

Dr. Marinkovich and Dr. Vakharia have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved the first-ever topical gene therapy, which will be used to treat wounds in patients 6 months of age and older who have either recessive or dominant dystrophic epidermolysis bullosa (DEB), a rare skin disease.

Olivier Le Moal/Getty Images

The therapy, Vyjuvek (beremagene geperpavec, formerly known as B-VEC), uses a nonreplicating herpes simplex virus type 1 (HSV-1) vector to deliver the COL7A1 gene directly to skin cells, restoring the COL7 protein fibrils that stabilize skin structure.

Vyjuvek, developed by Krystal Biotech, is designed to be used repetitively to heal a single wound or on more than one wound. In the pivotal study, the gene therapy, delivered in a topical gel, was administered once a week for 6 months.

The FDA gave Vyjuvek priority review, approving the therapy just 9 months after Krystal filed its application for approval. Vyjuvek is also an orphan drug, giving it potentially 7 years of marketing exclusivity.

“Vyjuvek is the first FDA-approved gene therapy treatment for DEB, a rare and serious genetic skin disorder,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the FDA’s statement  announcing the approval.

“With the FDA approval of Vyjuvek, the DEB population has reached a monumental milestone in the treatment of this horrible disorder,” said Brett Kopelan, executive director of debra of America, a national advocacy group for people with DEB, in a statement issued by Krystal Biotech. “Our hopes have now been realized for a safe and effective treatment for one of the most devastating symptoms of the disorder,” said Mr. Kopelan.

“This is a devastating disease,” said M. Peter Marinkovich, MD, primary investigator of Krystal’s pivotal GEM-3 trial and director of the Blistering Disease Clinic at Stanford Health Care, in the statement issued by Krystal. “Until now, doctors and nurses had no way to stop blisters and wounds from developing on dystrophic EB patient skin, and all we could do was to give them bandages and helplessly watch as new blisters formed,” said Dr. Marinkovich, who is also associate professor of dermatology at Stanford (Calif.) University School of Medicine.

“Because it’s safe and easy to apply directly to wounds, it doesn’t require a lot of supporting technology or specialized expertise, making Vyjuvek highly accessible even to patients who live far away from specialized centers,” he said.

Paras P. Vakharia, MD, PharmD, assistant professor of dermatology at Northwestern University, Chicago, said that Vyjuvek is an important advance for DEB. “This to me would be a treatment that I would consider for almost all patients,” Dr. Vakharia said in an interview.

Dr. Vakharia, who was not involved with trials of Vyjuvek, said he had concerns about whether patients might develop antibodies to either HSV or C7 but that the greater initial worry is if Vyjuvek will be affordable and accessible. “I envision that it will be a costly medication,” he said.

Mr. Kopelan, the patient advocate, said that his organization “will continue to work closely with Krystal to assure patients have ready access to Vyjuvek.”

Krystal did not respond before press time to a request for comment on pricing.

Dystrophic epidermolysis bullosa affects 1 to 3 people per million in the United States. It is caused by mutations in the COL7A1 gene, which encodes the alpha-1 chain of collagen type VII (C7) protein. C7 forms the anchoring fibrils that attach the epidermis to the underlying dermal connective tissue. COL71A mutations that lead to defective, decreased, or absent C7 can make the skin so fragile that it tears with the slightest touch.

DEB usually presents at birth and is divided into two major types depending on the inheritance pattern: recessive dystrophic epidermolysis bullosa and dominant dystrophic epidermolysis bullosa.

People with the dominant form typically have mild cases with blistering primarily on the hands, feet, knees, and elbows. The recessive form can be painful and debilitating, causing widespread blistering. Depending on the severity, it can lead to nonhealing wounds, fusing of fingers and toes, anemia, weak bones, and esophageal and genitourinary strictures. Squamous cell cancers are a frequent cause of death.

Vyjuvek is mixed into an inactive gel and is evenly applied to a wound once a week by a health care professional, according to the FDA.  

The agency recommends the following precautions for patients and caregivers:

• Avoid direct contact with treated wounds and dressings of treated wounds for 24 hours following application. Clean any area that is accidentally exposed.
• Wash hands and wear protective gloves when changing wound dressings.
• Disinfect the bandages used for the first dressing with a viricidal agent, such as 70% isopropyl alcohol, 6% hydrogen peroxide, or less than 0.4% ammonium chloride, and dispose of them in a separate, sealed plastic bag in household waste. Subsequent used dressings and cleaning materials should be disposed of in sealed plastic bags in household waste.

FDA approval of Vyjuvek was based on a randomized, double-blinded, placebo-controlled, 31-patient, phase 3 trial published in the New England Journal of Medicine, which showed that 71% of wounds treated with the gene therapy had complete healing at 3 months, compared with 20% of those treated with placebo (95% confidence interval, 29-73; P < .001). At 6 months, 67% of wounds treated with the gene therapy had complete healing, compared with 22% of wounds treated with placebo (95% CI, 24-68; P = .002).

Almost two-thirds of the patients had at least one adverse event. Most were mild or moderate. The most common events were pruritus, chills, and squamous cell carcinoma, reported in three patients each. SCC cases occurred at wound sites that had not been exposed to Vyjuvek or placebo. Serious adverse events, which were unrelated to the treatment, occurred in three patients and included diarrhea, anemia, and cellulitis.

Krystal will also be seeking marketing approval for Vyjuvek in the European Union, likely in 2024, said the company. In September, the European Medicines Agency’s Pediatric Committee issued a positive opinion on the gene therapy and Krystal’s plan to test B-VEC in children.

Dr. Marinkovich and Dr. Vakharia have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.
 

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.

In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).

The FDA had granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.
 

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.

In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).

The FDA had granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared Beta Bionics’s iLet ACE Pump and the iLet Dosing Decision Software for people ages 6 years and older with type 1 diabetes.
 

Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.

Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.

In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).

The FDA had granted the iLet a breakthrough device designation in December 2019.

Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.

Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”

That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”

On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”

The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the oral Janus kinase (JAK) inhibitor upadacitinib for adults with moderately to severely active Crohn’s disease whose condition failed to respond adequately or who can’t tolerate one or more tumor necrosis factor (TNF) inhibitors, the company has announced.

Upadacitinib (Rinvoq, AbbVie) is the first oral small molecule approved by the FDA for Crohn’s disease, which is noteworthy, said Kristin E. Burke, MD, MPH, medical director of clinical operations for the Massachusetts General Hospital Crohn’s and Colitis Center, Boston.

Massachusetts General Hospital

“Crohn’s disease is a complex immune-mediated disease for which more effective and fast-acting treatment options are needed. The approval of upadacitinib for anti-TNF refractory Crohn’s disease represents an important milestone in the expansion of treatment options for this disease as the first oral small molecule available,” she said.

The approval for Crohn’s disease was supported by data from two induction studies (U-EXCEED and U-EXCEL) and one maintenance study (U-ENDURE).

In the two induction studies, 857 patients were randomly assigned to receive upadacitinib 45 mg or placebo once daily for 12 weeks. At week 12, a greater proportion of patients who received upadacitinib (vs. those who received placebo) achieved clinical remission, as determined on the basis of the Crohn’s Disease Activity Index (CDAI), and improvement in intestinal inflammation as assessed by colonoscopy.

In the maintenance study, 343 patients who responded to induction therapy with upadacitinib were randomly assigned to receive either a maintenance regimen of 15 or 30 mg once daily or placebo for 52 weeks.

At week 52, a greater proportion of patients who were treated with upadacitinib 15 mg or 30 mg, compared with those who received placebo, achieved clinical remission.

Data from the trials of upadacitinib in Crohn’s disease were presented at the European Crohn’s and Colitis Organisation (ECCO) 2023 Congress in March.

“Symptoms of moderately to severely active Crohn’s disease can be disruptive and uncomfortable for patients, so relief as early as possible is key. Given the progressive nature of the disease, endoscopic response is just as important,” U-EXCEL study investigator Edward V. Loftus Jr., MD, professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minn., said in a news release.

“Based on the clinical trial results, treatment with Rinvoq shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation,” he said.

Patients should initially be given 45 mg of upadacitinib once daily for 12 weeks. After 12 weeks, the recommended maintenance dosage is 15 mg once a day. A maintenance dose of 30 mg once daily can be considered for patients with refractory, severe, or extensive Crohn’s disease, the FDA said in a statement announcing approval.

The most common side effects of upadacitinib in patients with Crohn’s disease are upper respiratory tract infection, anemia, fever, acne, herpes zoster, and headache.

Upadacitinib is not recommended for use in combination with other JAK inhibitors, biological therapies for Crohn’s disease, or with strong immunosuppressants, such as azathioprine and cyclosporine.

Serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis have occurred with JAK inhibitors such as upadacitinib.

The indication in Crohn’s disease marks the seventh in the United States for the JAK inhibitor. Other indications include rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Full prescribing information is available online.

Dr. Burke disclosed no conflicts. Dr. Loftus is a consultant and adviser for AbbVie.
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the oral Janus kinase (JAK) inhibitor upadacitinib for adults with moderately to severely active Crohn’s disease whose condition failed to respond adequately or who can’t tolerate one or more tumor necrosis factor (TNF) inhibitors, the company has announced.

Upadacitinib (Rinvoq, AbbVie) is the first oral small molecule approved by the FDA for Crohn’s disease, which is noteworthy, said Kristin E. Burke, MD, MPH, medical director of clinical operations for the Massachusetts General Hospital Crohn’s and Colitis Center, Boston.

Massachusetts General Hospital

“Crohn’s disease is a complex immune-mediated disease for which more effective and fast-acting treatment options are needed. The approval of upadacitinib for anti-TNF refractory Crohn’s disease represents an important milestone in the expansion of treatment options for this disease as the first oral small molecule available,” she said.

The approval for Crohn’s disease was supported by data from two induction studies (U-EXCEED and U-EXCEL) and one maintenance study (U-ENDURE).

In the two induction studies, 857 patients were randomly assigned to receive upadacitinib 45 mg or placebo once daily for 12 weeks. At week 12, a greater proportion of patients who received upadacitinib (vs. those who received placebo) achieved clinical remission, as determined on the basis of the Crohn’s Disease Activity Index (CDAI), and improvement in intestinal inflammation as assessed by colonoscopy.

In the maintenance study, 343 patients who responded to induction therapy with upadacitinib were randomly assigned to receive either a maintenance regimen of 15 or 30 mg once daily or placebo for 52 weeks.

At week 52, a greater proportion of patients who were treated with upadacitinib 15 mg or 30 mg, compared with those who received placebo, achieved clinical remission.

Data from the trials of upadacitinib in Crohn’s disease were presented at the European Crohn’s and Colitis Organisation (ECCO) 2023 Congress in March.

“Symptoms of moderately to severely active Crohn’s disease can be disruptive and uncomfortable for patients, so relief as early as possible is key. Given the progressive nature of the disease, endoscopic response is just as important,” U-EXCEL study investigator Edward V. Loftus Jr., MD, professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minn., said in a news release.

“Based on the clinical trial results, treatment with Rinvoq shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation,” he said.

Patients should initially be given 45 mg of upadacitinib once daily for 12 weeks. After 12 weeks, the recommended maintenance dosage is 15 mg once a day. A maintenance dose of 30 mg once daily can be considered for patients with refractory, severe, or extensive Crohn’s disease, the FDA said in a statement announcing approval.

The most common side effects of upadacitinib in patients with Crohn’s disease are upper respiratory tract infection, anemia, fever, acne, herpes zoster, and headache.

Upadacitinib is not recommended for use in combination with other JAK inhibitors, biological therapies for Crohn’s disease, or with strong immunosuppressants, such as azathioprine and cyclosporine.

Serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis have occurred with JAK inhibitors such as upadacitinib.

The indication in Crohn’s disease marks the seventh in the United States for the JAK inhibitor. Other indications include rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Full prescribing information is available online.

Dr. Burke disclosed no conflicts. Dr. Loftus is a consultant and adviser for AbbVie.
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the oral Janus kinase (JAK) inhibitor upadacitinib for adults with moderately to severely active Crohn’s disease whose condition failed to respond adequately or who can’t tolerate one or more tumor necrosis factor (TNF) inhibitors, the company has announced.

Upadacitinib (Rinvoq, AbbVie) is the first oral small molecule approved by the FDA for Crohn’s disease, which is noteworthy, said Kristin E. Burke, MD, MPH, medical director of clinical operations for the Massachusetts General Hospital Crohn’s and Colitis Center, Boston.

Massachusetts General Hospital

“Crohn’s disease is a complex immune-mediated disease for which more effective and fast-acting treatment options are needed. The approval of upadacitinib for anti-TNF refractory Crohn’s disease represents an important milestone in the expansion of treatment options for this disease as the first oral small molecule available,” she said.

The approval for Crohn’s disease was supported by data from two induction studies (U-EXCEED and U-EXCEL) and one maintenance study (U-ENDURE).

In the two induction studies, 857 patients were randomly assigned to receive upadacitinib 45 mg or placebo once daily for 12 weeks. At week 12, a greater proportion of patients who received upadacitinib (vs. those who received placebo) achieved clinical remission, as determined on the basis of the Crohn’s Disease Activity Index (CDAI), and improvement in intestinal inflammation as assessed by colonoscopy.

In the maintenance study, 343 patients who responded to induction therapy with upadacitinib were randomly assigned to receive either a maintenance regimen of 15 or 30 mg once daily or placebo for 52 weeks.

At week 52, a greater proportion of patients who were treated with upadacitinib 15 mg or 30 mg, compared with those who received placebo, achieved clinical remission.

Data from the trials of upadacitinib in Crohn’s disease were presented at the European Crohn’s and Colitis Organisation (ECCO) 2023 Congress in March.

“Symptoms of moderately to severely active Crohn’s disease can be disruptive and uncomfortable for patients, so relief as early as possible is key. Given the progressive nature of the disease, endoscopic response is just as important,” U-EXCEL study investigator Edward V. Loftus Jr., MD, professor of medicine in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minn., said in a news release.

“Based on the clinical trial results, treatment with Rinvoq shows both early and long-term symptom relief along with evidence of a visible reduction of damage to the intestinal lining caused by excess inflammation,” he said.

Patients should initially be given 45 mg of upadacitinib once daily for 12 weeks. After 12 weeks, the recommended maintenance dosage is 15 mg once a day. A maintenance dose of 30 mg once daily can be considered for patients with refractory, severe, or extensive Crohn’s disease, the FDA said in a statement announcing approval.

The most common side effects of upadacitinib in patients with Crohn’s disease are upper respiratory tract infection, anemia, fever, acne, herpes zoster, and headache.

Upadacitinib is not recommended for use in combination with other JAK inhibitors, biological therapies for Crohn’s disease, or with strong immunosuppressants, such as azathioprine and cyclosporine.

Serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis have occurred with JAK inhibitors such as upadacitinib.

The indication in Crohn’s disease marks the seventh in the United States for the JAK inhibitor. Other indications include rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Full prescribing information is available online.

Dr. Burke disclosed no conflicts. Dr. Loftus is a consultant and adviser for AbbVie.
 

A version of this article first appeared on Medscape.com.

The surge in drug overdose deaths in the United States during the first 2 years of the pandemic appears to have stabilized, according to newly released figures from the Centers for Disease Control and Prevention.

Overdose deaths in 2022 totaled an estimated 109,680 people, which is 2% more than the 107,573 deaths in 2021, according to the figures. But the 2022 total is still a record for the third straight year.

Public health officials are now in a hopeful position. If the 2022 data represents a peak, then the country will see deaths decline toward pre-pandemic levels. If overdose deaths instead have reached a plateau, it means that the United States will sustain the nearly 20% leap that came amid a deadly increase in drug use in 2020 and 2021.

“The fact that it does seem to be flattening out, at least at a national level, is encouraging,” Columbia University epidemiologist Katherine Keyes, PhD, MPH, told The Associated Press. “But these numbers are still extraordinarily high. We shouldn’t suggest the crisis is in any way over.”

The newly released figures from the CDC are considered estimates because some states may still send updated 2022 information later this year.

Although the number of deaths from 2021 to 2022 was stable on a national level, the picture varied more widely at the state level. More than half of U.S. states saw increases, while deaths in 23 states decreased, and just one – Iowa – had the same number of overdose deaths in 2021 and 2022.

The states with the highest counts in 2022 were:

• California: 11,978 deaths
• Florida: 8,032 deaths
• Texas: 5,607 deaths
• Pennsylvania: 5,222 deaths
• Ohio: 5,103 deaths

Synthetic opioids, such as fentanyl and tramadol, account for most drug overdose deaths, according to a December 2022 report from the CDC. 

State officials told The AP that they believe the plateau in overdose deaths is in part due to educational campaigns to warn the public about the dangers of drug use, as well as from expanded addiction treatment and increased access to the overdose-reversal medicine naloxone. 

A version of this article originally appeared on WebMD.com.

The surge in drug overdose deaths in the United States during the first 2 years of the pandemic appears to have stabilized, according to newly released figures from the Centers for Disease Control and Prevention.

Overdose deaths in 2022 totaled an estimated 109,680 people, which is 2% more than the 107,573 deaths in 2021, according to the figures. But the 2022 total is still a record for the third straight year.

Public health officials are now in a hopeful position. If the 2022 data represents a peak, then the country will see deaths decline toward pre-pandemic levels. If overdose deaths instead have reached a plateau, it means that the United States will sustain the nearly 20% leap that came amid a deadly increase in drug use in 2020 and 2021.

“The fact that it does seem to be flattening out, at least at a national level, is encouraging,” Columbia University epidemiologist Katherine Keyes, PhD, MPH, told The Associated Press. “But these numbers are still extraordinarily high. We shouldn’t suggest the crisis is in any way over.”

The newly released figures from the CDC are considered estimates because some states may still send updated 2022 information later this year.

Although the number of deaths from 2021 to 2022 was stable on a national level, the picture varied more widely at the state level. More than half of U.S. states saw increases, while deaths in 23 states decreased, and just one – Iowa – had the same number of overdose deaths in 2021 and 2022.

The states with the highest counts in 2022 were:

• California: 11,978 deaths
• Florida: 8,032 deaths
• Texas: 5,607 deaths
• Pennsylvania: 5,222 deaths
• Ohio: 5,103 deaths

Synthetic opioids, such as fentanyl and tramadol, account for most drug overdose deaths, according to a December 2022 report from the CDC. 

State officials told The AP that they believe the plateau in overdose deaths is in part due to educational campaigns to warn the public about the dangers of drug use, as well as from expanded addiction treatment and increased access to the overdose-reversal medicine naloxone. 

A version of this article originally appeared on WebMD.com.

The surge in drug overdose deaths in the United States during the first 2 years of the pandemic appears to have stabilized, according to newly released figures from the Centers for Disease Control and Prevention.

Overdose deaths in 2022 totaled an estimated 109,680 people, which is 2% more than the 107,573 deaths in 2021, according to the figures. But the 2022 total is still a record for the third straight year.

Public health officials are now in a hopeful position. If the 2022 data represents a peak, then the country will see deaths decline toward pre-pandemic levels. If overdose deaths instead have reached a plateau, it means that the United States will sustain the nearly 20% leap that came amid a deadly increase in drug use in 2020 and 2021.

“The fact that it does seem to be flattening out, at least at a national level, is encouraging,” Columbia University epidemiologist Katherine Keyes, PhD, MPH, told The Associated Press. “But these numbers are still extraordinarily high. We shouldn’t suggest the crisis is in any way over.”

The newly released figures from the CDC are considered estimates because some states may still send updated 2022 information later this year.

Although the number of deaths from 2021 to 2022 was stable on a national level, the picture varied more widely at the state level. More than half of U.S. states saw increases, while deaths in 23 states decreased, and just one – Iowa – had the same number of overdose deaths in 2021 and 2022.

The states with the highest counts in 2022 were:

• California: 11,978 deaths
• Florida: 8,032 deaths
• Texas: 5,607 deaths
• Pennsylvania: 5,222 deaths
• Ohio: 5,103 deaths

Synthetic opioids, such as fentanyl and tramadol, account for most drug overdose deaths, according to a December 2022 report from the CDC. 

State officials told The AP that they believe the plateau in overdose deaths is in part due to educational campaigns to warn the public about the dangers of drug use, as well as from expanded addiction treatment and increased access to the overdose-reversal medicine naloxone. 

A version of this article originally appeared on WebMD.com.

A resurgence of mpox this summer could be larger than last year’s caseload, the Centers for Disease Control and Prevention said in a warning to public health officials this week.

“The outbreak is not over,” the CDC alert stated, noting that springtime and summertime gatherings and festivals could lead to renewed virus spread. A new cluster of 13 cases is being investigated in Chicago, all among men, and four among people who recently traveled to New York City, New Orleans, or Mexico. 

Mpox, formerly called monkeypox, is a virus that causes a rash and sometimes flulike symptoms. It is most often transmitted through sexual contact, but it can also be spread in nonsexual ways that involve contact with skin lesions or with saliva or upper respiratory secretions like snot or mucus, the CDC says. Most cases in the United States have been among gay or bisexual men, men who have sex with men, and transgender people.

Last year, the U.S. government declared mpox a public health emergency as cases peaked at 460 per day in August, infecting more than 30,000 people and killing 42 people. Public health officials worked to quickly distribute vaccinations to people at high risk for contracting the virus. The CDC says 23% of people most at risk of getting mpox have been vaccinated.

The agency advises that people be vaccinated for mpox based on their potential exposure risk. Vaccination does not necessarily prevent infection but can lessen the severity of symptoms. Nine of the men who were recently infected in Chicago were fully vaccinated.

“It’s important to remember that vaccines, while incredibly helpful, are not our only way to reduce the risk of contracting mpox,” Richard Silvera, MD, MPH, of the department of infectious diseases at Icahn School of Medicine at Mount Sinai, New York, told ABC News. 

Other ways to reduce risk are “things like avoiding social and sexual contact if you have new skin lesions and asking your intimate contacts if they are experiencing symptoms or new skin changes,” Dr. Silvera said.

A version of this article first appeared on WebMD.com.

A resurgence of mpox this summer could be larger than last year’s caseload, the Centers for Disease Control and Prevention said in a warning to public health officials this week.

“The outbreak is not over,” the CDC alert stated, noting that springtime and summertime gatherings and festivals could lead to renewed virus spread. A new cluster of 13 cases is being investigated in Chicago, all among men, and four among people who recently traveled to New York City, New Orleans, or Mexico. 

Mpox, formerly called monkeypox, is a virus that causes a rash and sometimes flulike symptoms. It is most often transmitted through sexual contact, but it can also be spread in nonsexual ways that involve contact with skin lesions or with saliva or upper respiratory secretions like snot or mucus, the CDC says. Most cases in the United States have been among gay or bisexual men, men who have sex with men, and transgender people.

Last year, the U.S. government declared mpox a public health emergency as cases peaked at 460 per day in August, infecting more than 30,000 people and killing 42 people. Public health officials worked to quickly distribute vaccinations to people at high risk for contracting the virus. The CDC says 23% of people most at risk of getting mpox have been vaccinated.

The agency advises that people be vaccinated for mpox based on their potential exposure risk. Vaccination does not necessarily prevent infection but can lessen the severity of symptoms. Nine of the men who were recently infected in Chicago were fully vaccinated.

“It’s important to remember that vaccines, while incredibly helpful, are not our only way to reduce the risk of contracting mpox,” Richard Silvera, MD, MPH, of the department of infectious diseases at Icahn School of Medicine at Mount Sinai, New York, told ABC News. 

Other ways to reduce risk are “things like avoiding social and sexual contact if you have new skin lesions and asking your intimate contacts if they are experiencing symptoms or new skin changes,” Dr. Silvera said.

A version of this article first appeared on WebMD.com.

A resurgence of mpox this summer could be larger than last year’s caseload, the Centers for Disease Control and Prevention said in a warning to public health officials this week.

“The outbreak is not over,” the CDC alert stated, noting that springtime and summertime gatherings and festivals could lead to renewed virus spread. A new cluster of 13 cases is being investigated in Chicago, all among men, and four among people who recently traveled to New York City, New Orleans, or Mexico. 

Mpox, formerly called monkeypox, is a virus that causes a rash and sometimes flulike symptoms. It is most often transmitted through sexual contact, but it can also be spread in nonsexual ways that involve contact with skin lesions or with saliva or upper respiratory secretions like snot or mucus, the CDC says. Most cases in the United States have been among gay or bisexual men, men who have sex with men, and transgender people.

Last year, the U.S. government declared mpox a public health emergency as cases peaked at 460 per day in August, infecting more than 30,000 people and killing 42 people. Public health officials worked to quickly distribute vaccinations to people at high risk for contracting the virus. The CDC says 23% of people most at risk of getting mpox have been vaccinated.

The agency advises that people be vaccinated for mpox based on their potential exposure risk. Vaccination does not necessarily prevent infection but can lessen the severity of symptoms. Nine of the men who were recently infected in Chicago were fully vaccinated.

“It’s important to remember that vaccines, while incredibly helpful, are not our only way to reduce the risk of contracting mpox,” Richard Silvera, MD, MPH, of the department of infectious diseases at Icahn School of Medicine at Mount Sinai, New York, told ABC News. 

Other ways to reduce risk are “things like avoiding social and sexual contact if you have new skin lesions and asking your intimate contacts if they are experiencing symptoms or new skin changes,” Dr. Silvera said.

A version of this article first appeared on WebMD.com.

When the federal government’s public health emergency (PHE) ended on May 11, the Centers for Disease Control and Prevention scaled back the amount of COVID-related data that it had required hospitals to collect and report during the previous 3 years. The CDC had to do this, an agency spokesman said in an interview, because “CDC’s authorizations to collect certain types of public health data” expired with the PHE.

The question that arises from this policy change is whether the CDC will now have sufficient information on the evolution and spread of COVID to inform public health decisions in a timely manner. The CDC insists that it will have enough data to keep up with the virus, which repeatedly defied scientists’ expectations during the course of the pandemic. But some experts have doubts about whether this will turn out to be the case.

While the COVID pandemic is subsiding and transitioning to an endemic phase, many things about the coronavirus are still not understood, noted Marisa Eisenberg, PhD, associate professor of epidemiology at the University of Michigan, Ann Arbor.

“COVID is here to stay, and it ebbs and flows but is staying at fairly consistent levels across the country,” she said in an interview. “Meanwhile, we haven’t established a regular seasonality for COVID that we see for most other respiratory illnesses. We’re still seeing pretty rapidly invading new waves of variants. With flu and other respiratory illnesses, you often see a particular variant in each season. There’s an established pattern. For COVID, that’s still shifting.”

Similarly, Sam Scarpino, PhD, a public health expert at Northeastern University, Boston, told the New York Times: “The CDC is shuffling COVID into the deck of infectious diseases that we’re satisfied living with. One thousand deaths a week is just unacceptable.”

William Schaffner, MD, a professor of preventive medicine and health policy at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview that “how we deal with influenza is something of a template or a model for what the CDC is trying to get to with COVID.” It’s not practical for physicians and hospitals to report every flu case, and the same is now true for COVID. However, “we’re still asking for data on people who are hospitalized with COVID to be reported. That will give us a measure of the major public health impact.”

Dr. Eisenberg doesn’t fully subscribe to this notion. “COVID and influenza are both respiratory illnesses, and our initial pandemic response was based on playbooks that we’d built for potential flu pandemics. But COVID is not the flu. We still have to grapple with the fact that it’s killing a lot more people than the flu does. So maybe it’s a template, but not a perfect one.”
 

What data is being deleted

The CDC is now requiring hospitals to submit COVID-related data weekly, rather than daily, as it previously had. In addition, the agency has cut the number of data elements that hospitals must report from 62 to 44. Among the data fields that are now optional for hospitals to report are the numbers of hospitalized children with suspected or lab-confirmed COVID; hospitalized and ventilated COVID patients; adults in the ICU with suspected or lab-confirmed COVID; adult and pediatric admissions with suspected COVID; COVID-related emergency department visits; and inpatients with hospital-acquired COVID.

Although widely feared by health care workers and the public, hospital-acquired COVID has never been a major factor in the pandemic, Dr. Schaffner said. “So why ask for something that’s actually not so critical? Let’s keep the emphasis on rapid, accurate reporting of people who are hospitalized because of this disease.”

Akin Demehin, senior director for quality and patient safety policy for the American Hospital Association, agreed that the rate of hospital-acquired COVID cases “has been very low throughout the pandemic.” That was one reason why CDC made this measure optional.

Dr. Eisenberg concurred with this view. “We worried about [hospital-acquired COVID] a lot, and then, because people were very careful, it wasn’t as much of a problem as we feared it would be.” But she added a note of caution: “Masking and other [preventive guidelines] are shifting in hospitals, so it will be interesting to see whether that affects things.”
 

CDC justifies its new policy

To put the hospital data reporting changes in context, it’s important to know that CDC will no longer directly track community levels of COVID and the percentage of tests that come back positive for COVID, which until now were used to measure transmission rates. (Laboratories no longer have to report these test data, whether they are in hospitals or in the community.) To track death rates, CDC will rely on the National Vital Statistics System, which is accurate but lags other kinds of surveillance by 2-3 weeks, according to the New York Times.

In a recent MMWR report, CDC defended its new COVID surveillance system, saying: “Weekly COVID-19 hospital admission levels and the percentage of all COVID-19–associated deaths will be primary surveillance indicators. Emergency department visits and percentage of positive SARS-CoV-2 laboratory test results will help detect early changes in trends. Genomic surveillance will continue to help identify and monitor SARS-CoV-2 variants.”

Clarifying the latter point, CDC said that national genomic surveillance, along with wastewater surveillance, will continue to be used to estimate COVID variant proportions. Dr. Eisenberg stressed the importance of genomic surveillance at the hundreds of sites that CDC now maintains across the country. But currently, many of these sites are only monitoring the level of COVID.

CDC also observed that COVID-19 hospital admission levels have been shown to be “concordant” with community levels of SARS-CoV-2 infection. Therefore, rates of COVID-associated admissions and the percentages of positive test results, COVID ED visits, and COVID deaths are “suitable and timely indicators of trends in COVID-19 activity and severity.”
 

Ready to shift to voluntary reporting?

In a news release, AHA praised the “streamlining” of CDC requirements for data reporting but said that it hoped that mandatory reporting would be phased out as soon as possible.

The association noted that this would require action by the Centers for Medicare & Medicaid Services. CMS now enforces the CDC requirements with a “condition of participation” (COP) provision, by which noncompliant hospitals could be excluded from Medicare. CMS has extended this COP to April 30, 2024, although it could choose to ask the Secretary of Health and Human Services to terminate it earlier.

If mandatory reporting were repealed, would most hospitals still report on the key COVID metrics? Mr. Demehin noted that before CMS implemented its COP, hospitals reported COVID data voluntarily, “and the participation rate was well over 90%. So setting up a mechanism similar to that is something we’ve encouraged CMS to consider.”

Dr. Eisenberg is skeptical. While bigger hospitals with more resources might continue reporting voluntarily, she said, safety-net hospitals in underserved areas might not, because they are especially short staffed. “Then you have disparities in which hospitals will report.”
 

Vaccinations: The sleeping dragon

COVID continues to ravage the nation. According to CDC statistics, there were 1,109 deaths from COVID in the U.S. in the week ending May 6, and total deaths have hit 1.13 million. There were 1,333 new COVID-related hospital admissions, and 7,261 people were in the hospital because of COVID.

Another eye-catching number: Only 16.9% of the U.S. population has received an updated COVID vaccine booster. Dr. Schaffner thinks that this is what we should really keep our eye on. While the combination of vaccinations and widespread SARS-CoV-2 infections has conferred herd immunity on most Americans, he said it’s temporary. “Whether your immunity comes from the virus and recovery from disease or from the vaccines, that immunity will wane over time. Unless we keep our vaccination rate up, we may see more future cases. We’ll have to see how that works out. But I’m nervous about that, because people do appear to be nonchalant.”

A version of this article first appeared on Medscape.com.

When the federal government’s public health emergency (PHE) ended on May 11, the Centers for Disease Control and Prevention scaled back the amount of COVID-related data that it had required hospitals to collect and report during the previous 3 years. The CDC had to do this, an agency spokesman said in an interview, because “CDC’s authorizations to collect certain types of public health data” expired with the PHE.

The question that arises from this policy change is whether the CDC will now have sufficient information on the evolution and spread of COVID to inform public health decisions in a timely manner. The CDC insists that it will have enough data to keep up with the virus, which repeatedly defied scientists’ expectations during the course of the pandemic. But some experts have doubts about whether this will turn out to be the case.

While the COVID pandemic is subsiding and transitioning to an endemic phase, many things about the coronavirus are still not understood, noted Marisa Eisenberg, PhD, associate professor of epidemiology at the University of Michigan, Ann Arbor.

“COVID is here to stay, and it ebbs and flows but is staying at fairly consistent levels across the country,” she said in an interview. “Meanwhile, we haven’t established a regular seasonality for COVID that we see for most other respiratory illnesses. We’re still seeing pretty rapidly invading new waves of variants. With flu and other respiratory illnesses, you often see a particular variant in each season. There’s an established pattern. For COVID, that’s still shifting.”

Similarly, Sam Scarpino, PhD, a public health expert at Northeastern University, Boston, told the New York Times: “The CDC is shuffling COVID into the deck of infectious diseases that we’re satisfied living with. One thousand deaths a week is just unacceptable.”

William Schaffner, MD, a professor of preventive medicine and health policy at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview that “how we deal with influenza is something of a template or a model for what the CDC is trying to get to with COVID.” It’s not practical for physicians and hospitals to report every flu case, and the same is now true for COVID. However, “we’re still asking for data on people who are hospitalized with COVID to be reported. That will give us a measure of the major public health impact.”

Dr. Eisenberg doesn’t fully subscribe to this notion. “COVID and influenza are both respiratory illnesses, and our initial pandemic response was based on playbooks that we’d built for potential flu pandemics. But COVID is not the flu. We still have to grapple with the fact that it’s killing a lot more people than the flu does. So maybe it’s a template, but not a perfect one.”
 

What data is being deleted

The CDC is now requiring hospitals to submit COVID-related data weekly, rather than daily, as it previously had. In addition, the agency has cut the number of data elements that hospitals must report from 62 to 44. Among the data fields that are now optional for hospitals to report are the numbers of hospitalized children with suspected or lab-confirmed COVID; hospitalized and ventilated COVID patients; adults in the ICU with suspected or lab-confirmed COVID; adult and pediatric admissions with suspected COVID; COVID-related emergency department visits; and inpatients with hospital-acquired COVID.

Although widely feared by health care workers and the public, hospital-acquired COVID has never been a major factor in the pandemic, Dr. Schaffner said. “So why ask for something that’s actually not so critical? Let’s keep the emphasis on rapid, accurate reporting of people who are hospitalized because of this disease.”

Akin Demehin, senior director for quality and patient safety policy for the American Hospital Association, agreed that the rate of hospital-acquired COVID cases “has been very low throughout the pandemic.” That was one reason why CDC made this measure optional.

Dr. Eisenberg concurred with this view. “We worried about [hospital-acquired COVID] a lot, and then, because people were very careful, it wasn’t as much of a problem as we feared it would be.” But she added a note of caution: “Masking and other [preventive guidelines] are shifting in hospitals, so it will be interesting to see whether that affects things.”
 

CDC justifies its new policy

To put the hospital data reporting changes in context, it’s important to know that CDC will no longer directly track community levels of COVID and the percentage of tests that come back positive for COVID, which until now were used to measure transmission rates. (Laboratories no longer have to report these test data, whether they are in hospitals or in the community.) To track death rates, CDC will rely on the National Vital Statistics System, which is accurate but lags other kinds of surveillance by 2-3 weeks, according to the New York Times.

In a recent MMWR report, CDC defended its new COVID surveillance system, saying: “Weekly COVID-19 hospital admission levels and the percentage of all COVID-19–associated deaths will be primary surveillance indicators. Emergency department visits and percentage of positive SARS-CoV-2 laboratory test results will help detect early changes in trends. Genomic surveillance will continue to help identify and monitor SARS-CoV-2 variants.”

Clarifying the latter point, CDC said that national genomic surveillance, along with wastewater surveillance, will continue to be used to estimate COVID variant proportions. Dr. Eisenberg stressed the importance of genomic surveillance at the hundreds of sites that CDC now maintains across the country. But currently, many of these sites are only monitoring the level of COVID.

CDC also observed that COVID-19 hospital admission levels have been shown to be “concordant” with community levels of SARS-CoV-2 infection. Therefore, rates of COVID-associated admissions and the percentages of positive test results, COVID ED visits, and COVID deaths are “suitable and timely indicators of trends in COVID-19 activity and severity.”
 

Ready to shift to voluntary reporting?

In a news release, AHA praised the “streamlining” of CDC requirements for data reporting but said that it hoped that mandatory reporting would be phased out as soon as possible.

The association noted that this would require action by the Centers for Medicare & Medicaid Services. CMS now enforces the CDC requirements with a “condition of participation” (COP) provision, by which noncompliant hospitals could be excluded from Medicare. CMS has extended this COP to April 30, 2024, although it could choose to ask the Secretary of Health and Human Services to terminate it earlier.

If mandatory reporting were repealed, would most hospitals still report on the key COVID metrics? Mr. Demehin noted that before CMS implemented its COP, hospitals reported COVID data voluntarily, “and the participation rate was well over 90%. So setting up a mechanism similar to that is something we’ve encouraged CMS to consider.”

Dr. Eisenberg is skeptical. While bigger hospitals with more resources might continue reporting voluntarily, she said, safety-net hospitals in underserved areas might not, because they are especially short staffed. “Then you have disparities in which hospitals will report.”
 

Vaccinations: The sleeping dragon

COVID continues to ravage the nation. According to CDC statistics, there were 1,109 deaths from COVID in the U.S. in the week ending May 6, and total deaths have hit 1.13 million. There were 1,333 new COVID-related hospital admissions, and 7,261 people were in the hospital because of COVID.

Another eye-catching number: Only 16.9% of the U.S. population has received an updated COVID vaccine booster. Dr. Schaffner thinks that this is what we should really keep our eye on. While the combination of vaccinations and widespread SARS-CoV-2 infections has conferred herd immunity on most Americans, he said it’s temporary. “Whether your immunity comes from the virus and recovery from disease or from the vaccines, that immunity will wane over time. Unless we keep our vaccination rate up, we may see more future cases. We’ll have to see how that works out. But I’m nervous about that, because people do appear to be nonchalant.”

A version of this article first appeared on Medscape.com.

When the federal government’s public health emergency (PHE) ended on May 11, the Centers for Disease Control and Prevention scaled back the amount of COVID-related data that it had required hospitals to collect and report during the previous 3 years. The CDC had to do this, an agency spokesman said in an interview, because “CDC’s authorizations to collect certain types of public health data” expired with the PHE.

The question that arises from this policy change is whether the CDC will now have sufficient information on the evolution and spread of COVID to inform public health decisions in a timely manner. The CDC insists that it will have enough data to keep up with the virus, which repeatedly defied scientists’ expectations during the course of the pandemic. But some experts have doubts about whether this will turn out to be the case.

While the COVID pandemic is subsiding and transitioning to an endemic phase, many things about the coronavirus are still not understood, noted Marisa Eisenberg, PhD, associate professor of epidemiology at the University of Michigan, Ann Arbor.

“COVID is here to stay, and it ebbs and flows but is staying at fairly consistent levels across the country,” she said in an interview. “Meanwhile, we haven’t established a regular seasonality for COVID that we see for most other respiratory illnesses. We’re still seeing pretty rapidly invading new waves of variants. With flu and other respiratory illnesses, you often see a particular variant in each season. There’s an established pattern. For COVID, that’s still shifting.”

Similarly, Sam Scarpino, PhD, a public health expert at Northeastern University, Boston, told the New York Times: “The CDC is shuffling COVID into the deck of infectious diseases that we’re satisfied living with. One thousand deaths a week is just unacceptable.”

William Schaffner, MD, a professor of preventive medicine and health policy at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview that “how we deal with influenza is something of a template or a model for what the CDC is trying to get to with COVID.” It’s not practical for physicians and hospitals to report every flu case, and the same is now true for COVID. However, “we’re still asking for data on people who are hospitalized with COVID to be reported. That will give us a measure of the major public health impact.”

Dr. Eisenberg doesn’t fully subscribe to this notion. “COVID and influenza are both respiratory illnesses, and our initial pandemic response was based on playbooks that we’d built for potential flu pandemics. But COVID is not the flu. We still have to grapple with the fact that it’s killing a lot more people than the flu does. So maybe it’s a template, but not a perfect one.”
 

What data is being deleted

The CDC is now requiring hospitals to submit COVID-related data weekly, rather than daily, as it previously had. In addition, the agency has cut the number of data elements that hospitals must report from 62 to 44. Among the data fields that are now optional for hospitals to report are the numbers of hospitalized children with suspected or lab-confirmed COVID; hospitalized and ventilated COVID patients; adults in the ICU with suspected or lab-confirmed COVID; adult and pediatric admissions with suspected COVID; COVID-related emergency department visits; and inpatients with hospital-acquired COVID.

Although widely feared by health care workers and the public, hospital-acquired COVID has never been a major factor in the pandemic, Dr. Schaffner said. “So why ask for something that’s actually not so critical? Let’s keep the emphasis on rapid, accurate reporting of people who are hospitalized because of this disease.”

Akin Demehin, senior director for quality and patient safety policy for the American Hospital Association, agreed that the rate of hospital-acquired COVID cases “has been very low throughout the pandemic.” That was one reason why CDC made this measure optional.

Dr. Eisenberg concurred with this view. “We worried about [hospital-acquired COVID] a lot, and then, because people were very careful, it wasn’t as much of a problem as we feared it would be.” But she added a note of caution: “Masking and other [preventive guidelines] are shifting in hospitals, so it will be interesting to see whether that affects things.”
 

CDC justifies its new policy

To put the hospital data reporting changes in context, it’s important to know that CDC will no longer directly track community levels of COVID and the percentage of tests that come back positive for COVID, which until now were used to measure transmission rates. (Laboratories no longer have to report these test data, whether they are in hospitals or in the community.) To track death rates, CDC will rely on the National Vital Statistics System, which is accurate but lags other kinds of surveillance by 2-3 weeks, according to the New York Times.

In a recent MMWR report, CDC defended its new COVID surveillance system, saying: “Weekly COVID-19 hospital admission levels and the percentage of all COVID-19–associated deaths will be primary surveillance indicators. Emergency department visits and percentage of positive SARS-CoV-2 laboratory test results will help detect early changes in trends. Genomic surveillance will continue to help identify and monitor SARS-CoV-2 variants.”

Clarifying the latter point, CDC said that national genomic surveillance, along with wastewater surveillance, will continue to be used to estimate COVID variant proportions. Dr. Eisenberg stressed the importance of genomic surveillance at the hundreds of sites that CDC now maintains across the country. But currently, many of these sites are only monitoring the level of COVID.

CDC also observed that COVID-19 hospital admission levels have been shown to be “concordant” with community levels of SARS-CoV-2 infection. Therefore, rates of COVID-associated admissions and the percentages of positive test results, COVID ED visits, and COVID deaths are “suitable and timely indicators of trends in COVID-19 activity and severity.”
 

Ready to shift to voluntary reporting?

In a news release, AHA praised the “streamlining” of CDC requirements for data reporting but said that it hoped that mandatory reporting would be phased out as soon as possible.

The association noted that this would require action by the Centers for Medicare & Medicaid Services. CMS now enforces the CDC requirements with a “condition of participation” (COP) provision, by which noncompliant hospitals could be excluded from Medicare. CMS has extended this COP to April 30, 2024, although it could choose to ask the Secretary of Health and Human Services to terminate it earlier.

If mandatory reporting were repealed, would most hospitals still report on the key COVID metrics? Mr. Demehin noted that before CMS implemented its COP, hospitals reported COVID data voluntarily, “and the participation rate was well over 90%. So setting up a mechanism similar to that is something we’ve encouraged CMS to consider.”

Dr. Eisenberg is skeptical. While bigger hospitals with more resources might continue reporting voluntarily, she said, safety-net hospitals in underserved areas might not, because they are especially short staffed. “Then you have disparities in which hospitals will report.”
 

Vaccinations: The sleeping dragon

COVID continues to ravage the nation. According to CDC statistics, there were 1,109 deaths from COVID in the U.S. in the week ending May 6, and total deaths have hit 1.13 million. There were 1,333 new COVID-related hospital admissions, and 7,261 people were in the hospital because of COVID.

Another eye-catching number: Only 16.9% of the U.S. population has received an updated COVID vaccine booster. Dr. Schaffner thinks that this is what we should really keep our eye on. While the combination of vaccinations and widespread SARS-CoV-2 infections has conferred herd immunity on most Americans, he said it’s temporary. “Whether your immunity comes from the virus and recovery from disease or from the vaccines, that immunity will wane over time. Unless we keep our vaccination rate up, we may see more future cases. We’ll have to see how that works out. But I’m nervous about that, because people do appear to be nonchalant.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has expanded the indication for Abbott Laboratories’ spinal cord stimulation (SCS) devices to include treatment of chronic back pain in patients who have not had, or are not eligible for, back surgery, the company has announced.
 

The new indication spans all of Abbott’s SCS devices in the United States, which include the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform.

The devices feature the company’s proprietary, low-energy BurstDR stimulation waveform, a form of stimulation therapy that uses bursts of mild electrical energy without causing an abnormal tingling sensation to help disrupt pain signals before they can reach the brain, the company explained.

The expanded indication was supported by results from the DISTINCT study, which enrolled 270 adults suffering from severe, disabling chronic back pain for an average of more than 12 years and who were not eligible for surgery.

The study showed that significantly more patients who were treated with SCS achieved significant improvements in back pain, function, quality of life, and psychological status than peers treated with conservative medical management.

“To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for non-surgical back pain,” Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, W.Va., said in a news release.

“This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain,” Dr. Deer said.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has expanded the indication for Abbott Laboratories’ spinal cord stimulation (SCS) devices to include treatment of chronic back pain in patients who have not had, or are not eligible for, back surgery, the company has announced.
 

The new indication spans all of Abbott’s SCS devices in the United States, which include the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform.

The devices feature the company’s proprietary, low-energy BurstDR stimulation waveform, a form of stimulation therapy that uses bursts of mild electrical energy without causing an abnormal tingling sensation to help disrupt pain signals before they can reach the brain, the company explained.

The expanded indication was supported by results from the DISTINCT study, which enrolled 270 adults suffering from severe, disabling chronic back pain for an average of more than 12 years and who were not eligible for surgery.

The study showed that significantly more patients who were treated with SCS achieved significant improvements in back pain, function, quality of life, and psychological status than peers treated with conservative medical management.

“To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for non-surgical back pain,” Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, W.Va., said in a news release.

“This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain,” Dr. Deer said.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has expanded the indication for Abbott Laboratories’ spinal cord stimulation (SCS) devices to include treatment of chronic back pain in patients who have not had, or are not eligible for, back surgery, the company has announced.
 

The new indication spans all of Abbott’s SCS devices in the United States, which include the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform.

The devices feature the company’s proprietary, low-energy BurstDR stimulation waveform, a form of stimulation therapy that uses bursts of mild electrical energy without causing an abnormal tingling sensation to help disrupt pain signals before they can reach the brain, the company explained.

The expanded indication was supported by results from the DISTINCT study, which enrolled 270 adults suffering from severe, disabling chronic back pain for an average of more than 12 years and who were not eligible for surgery.

The study showed that significantly more patients who were treated with SCS achieved significant improvements in back pain, function, quality of life, and psychological status than peers treated with conservative medical management.

“To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for non-surgical back pain,” Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, W.Va., said in a news release.

“This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain,” Dr. Deer said.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has announced new action to address ongoing concerns about misuse, abuse, addiction, and overdose of prescription stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.

Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.

The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

Patient medication guides will be updated to educate patients and caregivers about these risks.

The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
 

Friends and family

A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.

Misuse/abuse of a patient’s own prescription make up 10%-20% of people who report nonmedical stimulant use.

Less commonly reported sources include drug dealers or strangers (4%-7% of people who report nonmedical use) and the Internet (1%-2%).

The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18-25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.

Recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has announced new action to address ongoing concerns about misuse, abuse, addiction, and overdose of prescription stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.

Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.

The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

Patient medication guides will be updated to educate patients and caregivers about these risks.

The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
 

Friends and family

A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.

Misuse/abuse of a patient’s own prescription make up 10%-20% of people who report nonmedical stimulant use.

Less commonly reported sources include drug dealers or strangers (4%-7% of people who report nonmedical use) and the Internet (1%-2%).

The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18-25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.

Recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
 

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has announced new action to address ongoing concerns about misuse, abuse, addiction, and overdose of prescription stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.

Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.

The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

Patient medication guides will be updated to educate patients and caregivers about these risks.

The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
 

Friends and family

A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.

Misuse/abuse of a patient’s own prescription make up 10%-20% of people who report nonmedical stimulant use.

Less commonly reported sources include drug dealers or strangers (4%-7% of people who report nonmedical use) and the Internet (1%-2%).

The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18-25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.

Recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
 

A version of this article first appeared on Medscape.com.