AstraZeneca Says Nirsevimab Recommended for RSV Prevention in Infants by FDA Body

By Joe Hoppe

AstraZeneca said Friday that its nirsevimab antibody has been recommended for the prevention of respiratory syncytial virus, a lower respiratory tract disease, in infants by a U.S. Food and Drug Administration committee.

The pharmaceutical major said that if approved, nirsevimab would be the first preventive option specifically designed to protect infants through their first RSV season, including both healthy infants and those with specific health conditions that make them vulnerable to the disease.

The antibody is being developed jointly by AstraZeneca and Sanofi.

The company said that against all clinical endpoints, a single dose of the drug delivered consistent, sustained efficacy against RSV when compared to a placebo.

The FDA had accepted an a biologics license application for the drug in 2022, and has indicated it will expedite its review, the company said. The Prescription Drug User Fee Act date is in the third quarter of 2023, and if approved by then, nirsevimab will be available in the U.S. ahead of the 2023-24 RSV season, AstraZeneca said.

The recommendation was based on a clinical development program spanning three late-stage clinical trials, where it was generally well-tolerated with a favorable safety profile.

Write to Joe Hoppe at [e-mail]

(END) Dow Jones Newswires

June 09, 2023 02:55 ET (06:55 GMT)

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