Unanimous Support for AstraZeneca and Sanofi's Nirsevimab: Next Generation RSV Treatment on the Horizon -
Benzinga The FDA's Antimicrobial Drugs Advisory Committee has voted unanimously 21 to 0 thatAstraZeneca plcAZN andSanofi SA'sSNY nirsevimab has a favorable benefit-risk profile to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during orentering 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.
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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.
ReutersnotesthatSwedish Orphan Biovitrum AB'sBIOVF Synagis is currently the only approved preventive therapy in the U.S. for high-risk infants against RSV.
