AstraZeneca’s BLA for nirsevimab in RSV prevention accepted by FDA for review

The company states: "AstraZeneca’s Biologics License Application for nirsevimab has been accepted for review by the FDA for the prevention of respiratory syncytial virus 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. Nirsevimab is being developed and commercialised by AstraZeneca in collaboration with Sanofi and is the first single-dose preventative option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. The FDA has indicated it will work to expedite its review. The Prescription Drug User Fee Act date, the FDA target action date for its decision, is in the third quarter of 2023. If approved at that time, nirsevimab will be available in the US for the 2023/2024 RSV season. RSV is a very contagious virus that can lead to serious respiratory illness, according to the Centers for Disease Control and Prevention. In the US, RSV is the leading cause of hospitalisation for babies under one. Any infant can be hospitalised in their first RSV season and about 75% of infants hospitalised for RSV in the US were born at term with no underlying conditions."Reference Link