FDA approves monoclonal antibody to prevent RSV in infants

Key takeaways:

• The FDA approved a monoclonal antibody to prevent respiratory syncytial virus in children during their initial RSV seasons.
• Data shows nirsevimab protects against medically attended RSV in newborns and infants.

The FDA on Monday approved a monoclonal antibody for the prevention of respiratory syncytial virus lower respiratory tract disease in newborn and infants.

Beyfortus (nirsevimab, AstraZeneca and Sanofi) is approved for neonates and infants born during or entering their first RSV season and for children up to age 24 months who remain vulnerable to severe illness from the virus through their second RSV season.

The FDA’s Antimicrobial Drugs Advisory Committee voted unanimously last month to recommend nirsevimab for approval at an intramuscular injection of 50 mg for infants with a body weight less than 5 kg, and 100 mg for infants with a body weight of 5 kg or more.

The CDC’s Advisory Committee on Immunization Practices will meet Aug. 3 to discuss federal recommendations for nirsevimab, according to a notice that will be published Tuesday in the Federal Register.

AstraZeneca and Sanofi said they expect nirsevimab to be available before the upcoming RSV season in the United States, where RSV is the No. 1 cause of bronchiolitis and pneumonia in children aged younger than 1 year, according to the CDC.

“RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system.”

Trials of nirsevimab have reported promising results. Data from multiple trials, including the phase 3 MELODY trial, showed consistent protection of approximately 80% against medically attended RSV with a single dose.

The FDA approval was the latest in a series of recent regulatory decisions supporting medications that protect against RSV, a common respiratory infection that often causes serious illness not only in young children, but also older adults.

Earlier this year, GSK’s Arexvy became the first ever RSV vaccine to gain FDA approval, and early last month the agency also approved Pfizer’s RSV vaccine.

Both vaccines were approved only for older adults, but Pfizer’s vaccine is also under review by the FDA for use in pregnant people to protect their babies.

References:

• Beyfortus approved in the US for the prevention of RSV lower respiratory tract disease in infants. https://www.astrazeneca.com/media-centre/press-releases/2023/beyfortus-approved-in-the-us-for-the-prevention-of-rsv-lower-respiratory-tract-disease-in-infants.html. Published July 17, 2023. Accessed July 17, 2023.
• CDC. Respiratory syncytial virus infection (RSV). https://www.cdc.gov/rsv/index.html.
• FDA approves new drug to prevent RSV in babies and toddlers. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers. Published July 17, 2023. Accessed July 17, 2023.
• Federal Register. Meetings: Advisory Committee on Immunization Practices. https://www.federalregister.gov/public-inspection/2023-15190/meetings-advisory-committee-on-immunization-practices. Published July 17, 2023. Accessed July 17, 2023.