By Fineline Cube 
France-based Sanofi (NASDAQ: SNY) announced plans to commence shipments of Beyfortus (nirsevimab) in early Q3 2025. This strategic move ensures broad availability of the therapy ahead of the 2025-2026 respiratory syncytial virus (RSV) season.
Beyfortus’ Role and Impact
Beyfortus is currently the only therapy providing RSV protection for all infants. Since its launch in 2023, Sanofi and its partner AstraZeneca have significantly scaled up production to meet global demand. The companies have tripled production capacity and doubled the number of manufacturing sites.
Regulatory Approvals and Market Expansion
Beyfortus received approval in the European Union (EU) in October 2022 for preventing RSV-associated lower respiratory tract infections in newborns and infants during their first RSV season. It subsequently gained marketing approvals in the US in July 2023 and in China in January 2024. Market filings for the drug are currently under review by multiple regulatory bodies worldwide.-Fineline Info & Tech