Nirsevimab recommended for approval in EU by CHMP
16 September 2022 07:00 BST Beyfortus (nirsevimab) recommended for approval in the EU by CHMP for the prevention of RSV lower respiratory tract disease in infants Recommendation is based on the Beyfortus clinical trial programme which demonstrated protection against RSV disease during the RSV season with a single dose If approved by the European Commission, Beyfortus would be the first preventative option for the broad newborn and infant population AstraZeneca and Sanofi's Beyfortus (nirsevimab) has been recommended for marketing authorisation in the European Union (EU) for the