FDA accepts BLA for nirsevimab prevention of RSV lower respiratory tract disease in infants

UK pharma major AstraZeneca (LSE: AZN) said today that its 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 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Nirsevimab is being developed and commercialized by AstraZeneca in collaboration with France’s Sanofi (Euronext: SAN) 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 drug was approved for this indication, under the trade name Beyfortus, by the European Commission in November last year. Additional global regulatory submissions are underway.

These development comes at a time when vaccines for RSV are also  closing in on the market, following years of unsuccessful development efforts, with candidates from Pfizer (NYSE: PFE) and GSK (LSE: GSK) leading the way.