The FDA’s Antimicrobial Drugs Advisory Committee has voted unanimously 21 to 0 that AstraZeneca plc (NASDAQ:AZN) and Sanofi SA’s (NASDAQ:SNY) nirsevimab has a favorable benefit-risk profile to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season.
The committee also voted 19 to 2 in support of nirsevimab’s favorable benefit-risk profile for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Related: Sanofi, AstraZeneca Release Real-World Data For Respiratory Syncytial Virus Antibody.
The FDA accepted the marketing application for nirsevimab in 2022, and the agency has indicated it will work to expedite its review. The Prescription Drug User Fee Act date is in Q3 of 2023.
Nirsevimab will be available in the US before the 2023-2024 RSV season if approved by then.
Reuters notes that Swedish Orphan Biovitrum AB’s (OTC:BIOVF) Synagis is currently the only approved preventive therapy in the U.S. for high-risk infants against RSV.
Unlike Synagis, which is given monthly injections, nirsevimab is a long-acting therapy expected to be given once every season.
According to Morningstar analyst, Nirsevimab’s peak sales are estimated at $2 billion.
Price Action: AZN shares are down 0.90% at $73.58, and SNY stock is down 0.95% at $51.05 during the premarket session on the last check Friday.
