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6h ago

FDA Opens Safety Reexamination of Infant RSV Antibody Therapies

Manufacturers were told to expect follow-up questions after internal reviewers flagged trial imbalances alongside outside seizure claims.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
FILE - The U.S. Food and Drug Administration building is seen behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md., Aug. 2, 2018. (AP Photo/Jacquelyn Martin, File)
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Overview

  • Senior executives at Merck, Sanofi and AstraZeneca were briefed last week that Beyfortus and Enflonsia will face fresh FDA safety scrutiny.
  • FDA said it is rigorously reviewing evidence and would update labeling if warranted, while no changes or restrictions have been announced.
  • Tracy Beth Hoeg, who began raising questions in June, has been named acting director of CDER and led the push to revisit the data.
  • Several safety studies have not found a seizure signal, and CDC real‑world analysis reported up to a 43% reduction in infant RSV hospitalizations in 2024–25.
  • At a recent advisory meeting, reviewers noted a non‑statistically‑significant mortality imbalance across four late‑stage trials that they consider worth reassessing.