AstraZeneca and Sanofi’s Beyfortus (nirsevimab) Receive the US FDA’s Approval for the Prevention of RSV Lower Respiratory Tract Disease in Infants
Shots:
- The US FDA has approved Beyfortus for RSV LRTD in newborns & infants born during or entering their first RSV season, and for children ~24mos. who remain vulnerable to sev. RSV disease through the 2nd RSV season. The therapy is expected to be available in the 2023-2024 RSV season
- The approval was based on the extensive clinical development program incl. 3 late-stage trials evaluating Beyfortus. The results showed that a single dose of Beyfortus demonstrated consistent efficacy against RSV LRTD through 5mos. across all clinical EPs, was well tolerated with a favorable safety profile consistent & overall rates of AEs were comparable b/w Beyfortus & PBO
- The therapy was approved in the EU, Great Britain & Canada while regulatory applications are under review in China, Japan & multiple other countries
Ref: AstraZeneca | Image: AstraZeneca
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
