AstraZeneca, Sanofi win FDA advisory committee backing for RSV therapy nirsevimab
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A U.S. Food and Drug Administration (FDA) advisory committee on Thursday voted in favor to recommend approval of Sanofi (NASDAQ:SNY) and AstraZeneca's (NASDAQ:AZN) antibody therapy to prevent respiratory syncytial virus (RSV) infection in newborn babies and infants.
The FDA's Antimicrobial Drugs Advisory Committee unanimously voted 21 to 0 in favor of using the therapy, nirsevimab, to prevent infections in newborns or infants in their first RSV season.
Separately, the committee voted 19 to 2 in favor of using nirsevimab in children up to two years of age who remain vulnerable to severe illness through their second RSV season.
Recommendations by the FDA's advisory committees are non-binding, but the regulator usually follows through with an approval on therapies that have been backed by such committees.
"Most babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact," Thomas Triomphe, executive VP of vaccines at Sanofi (SNY), said in a statement.
"We look forward to continuing to work with the FDA to complete their expedited review, and we hope to see nirsevimab available as soon as possible given the significant burden of RSV in infants," added Iskra Reic, executive VP of vaccines and immune therapies at AstraZeneca (AZN).
The FDA has given a so-called Prescription Drug User Fee Act date, or the date by which it is set to decide upon the biologics license application for nirsevimab, in Q3 of this year.
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