FDA Accepts BLA for RSV Prevention in Infants

The FDA has accepted a biologics license application (BLA) for nirsevimab to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and children up to 24 months of age. Nirsevimab is being developed and commercialized by AstraZeneca in collaboration with Sanofi. It is a single-dose, long-acting antibody designed to protect infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

The Prescription Drug User Fee Act date is in the third quarter of 2023. If approved at that time, nirsevimab will be available in the United States for the 2023/2024 RSV season.

William J. Muller, M.D., Ph.D.

“Effective interventions to prevent RSV are a critical need,” William J. Muller, M.D., Ph.D., associate professor, pediatrics, Northwestern University Feinberg School of Medicine, said in a press release. Muller is also scientific director, Clinical and Community Trials, Ann & Robert H. Lurie Children’s Hospital of Chicago. “This year in the US, we’ve seen first-hand how frightening the impact of this respiratory disease is on our patients and how stressful it is on the healthcare system, highlighting the urgency of addressing this problem.”

The BLA was based on results MELODY clinical trial program. Data from the MELODY phase 3 trial were published in the New England Journal of Medicine in March 2022 and demonstrated a reduction in the incidence of medically-attended lower respiratory tract infections caused by RSV by 74.5% compared with placebo through day 151. Nirsevimab also demonstrated a comparable safety and tolerability profile to Sobi’s Synagis (palivizumab), a monoclonal antibody also used to prevent RSV in infants, in the MEDLEY phase 2/3 trial, with occurrence of treatment emergent adverse events or treatment emergent serious adverse events similar between groups.

In November 2022, nirsevimab was granted marketing authorization in the European Union for the prevention of RSV lower respiratory tract disease in newborns and infants, under the name Beyfortus.