AstraZeneca and Sanofi’s Beyfortus (nirsevimab) Gets NMPA’s Approval for Preventing Respiratory Syncytial Virus (RSV) Infection in Infants
Shots:
- AZ & Sanofi's Beyfortus is approved by the NMPA for preventing RSV lower respiratory tract infection in neonates and infants during their first RSV season. It is expected to be available for the 2024-2025 RSV season
- The approval was grounded in 3 pivotal late-stage clinical studies and a comprehensive local clinical development program in which a single dose showed efficacy against RSV lower RTI for up to 5mos. (the typical RSV season)
- Furthermore, the regulatory reviews for Beyfortus are ongoing in Japan and other countries. It received EU approval in Oct '22 for preventing RSV LRTI in newborns and infants during their first RSV season & the US FDA approval in Jul '23
Ref: AstraZeneca | Image: AstraZeneca
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
