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# AstraZeneca RSV Drug Beyfortus Approved
- URL: https://www.fdaweb.com/astrazeneca-rsv-drug-beyfortus-approved/
- Published: 2023-07-17T12:00:00.000Z
- Updated: 2026-09-14T18:44:31.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154891

FDA has approved an AstraZeneca BLA for Beyfortus (nirsevimab-alip) for preventing Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age.

Approval of the monoclonal antibody was based on data from three clinical trials. “Among infants who were treated with Beyfortus, 25 (2.6%) experienced MA RSV LRTI compared with 46 (9.5%) infants who received placebo,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers?ref=fdaweb.com) says. “Beyfortus reduced the risk of MA RSV LRTI by approximately 70% relative to placebo.”

FDA says that possible side effects caused by Beyfortus include rash and injection site reactions. “Beyfortus should not be given to infants and children with a history of serious hypersensitivity reactions to Beyfortus' active ingredients or any of its excipients,” it says. Beyfortus’s labeling includes warnings and precautions about serious hypersensitivity reactions, including anaphylaxis, which have been observed with other monoclonal antibodies. “Beyfortus should be given with caution to infants and children with clinically significant bleeding disorders,” the agency says.