Sanofi says FDA accepts BLA for nirsevimab

The U.S. Food and Drug Administration Center for Drug Evaluation and Research has accepted the Biologics License Application, or BLA, for nirsevimab for the prevention of respiratory syncytial virus, or RSV, lower respiratory tract disease in newborns and 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, Sanofi (SNY) announced. Nirsevimab is being developed jointly by Sanofi and AstraZeneca (AZN) and, if approved, would be "the first protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions," Sanofi said. The FDA has indicated they will work to expedite their review. The Prescription Drug User Fee Act date, the FDA target action date for their decision, is in the third quarter of 2023.