FDA approves AZ/Sanofi’s Beyfortus® (nirsevimab) to treat RSV LRTD in newborns and infants

AstraZeneca and Sanofi announced that the FDA has approved Beyfortus® (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. It was also approved to treat children up to two years old who are vulnerable to severe RSV disease through their second RSV season.  The companies confirmed Beyfortus® will be available before the 2023/2024 RSV season.  The FDA approval follows a unanimous vote on 8 June 2023 by the Antimicrobial Drugs Advisory Committee (AMDAC) on the favourable benefit-risk profile of Beyfortus® based on the clinical development programme spanning three late-stage clinical trials.