AstraZeneca, Sanofi BLA for nirsevimab for respiratory syncytial virus accepted by FDA
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The US FDA has accepted a Biologics License Application from AstraZeneca (NASDAQ:AZN) and Sanofi (NASDAQ:SNY) for nirsevimab for the treatment of respiratory syncytial virus (RSV) in newborns, infants, and children up to 24 months old.
The candidate has an action date in Q3 of the year.

AstraZeneca (AZN) and Sanofi (SNY) say the application was supported by data from the phase 3 MELODY program, as well as phase 2 results. MELODY data demonstrated treatment with nirsevimab led to a reduction in medically-attended lower respiratory tract infections caused by RSV by 74.5% compared to placebo through day 151 with just one dose.
The European Commission approved nirsevimab in November 2022 under the brand name Beyfortus.