Shots :
- Merck’s ENFLONSIA has been approved by the US FDA to prevent RSV lower respiratory tract disease in newborns and infants entering their first RSV season, offering protection for up to 5mos. with a single 105mg dose, regardless of weight
- The approval was supported by the P-IIb/III (CLEVER) study of ENFLONSIA that demonstrated reduced RSV-associated lower respiratory infections by 60.5% (1EP) and hospitalizations by 84.3% (key 2EP) vs PBO. Additional P-III (SMART) study results supported its safety and efficacy, incl. in high-risk infants
- The US CDC committee will meet this month to recommend ENFLONSIA for infants; Ordering begins in July, with shipments expected before the 2025-2026 RSV season
Ref: Merck | Image: Merck | Press Release
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