Posted by Michael Wonder on 16 Sep 2022
CHMP recommends approval of Beyfortus (nirsevimab) for prevention of RSV disease in infants
16 September 2022 - Recommendation is based on the Beyfortus clinical trial program which demonstrated protection against medically attended lower respiratory tract infection caused by respiratory syncytial virus with a single dose during the respiratory syncytial virus season.
The EMA’s CHMP has adopted a positive opinion for Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus lower respiratory tract disease in newborns and infants during their first respiratory syncytial virus season.
