By IDSE News Staff
The FDA granted approval to nirsevimab-alip (Beyfortus, Sanofi/AstraZeneca) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season.
Nirsevimab-alip is also now indicated for children up to 24 months of age who are vulnerable to severe RSV disease through their second RSV season.
It is the first and only single-dose passive prophylaxis for RSV among a broad infant population, which