Nirsevimab US regulatory submission accepted for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months
If FDA approved, nirsevimab would be the first single-dose RSV preventative option for the broad newborn and infant population in the US.Submission supported by comprehensive clinical trial programme, which demonstrated protection against RSV disease through the RSV season.AstraZeneca’s Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season, and for children up to 24