The CHMP recommends the approval of Beyfortus® (noevimab) for the prevention of RSV disease in infants
- The recommendation is based on the Beyfortus clinical trials program, which demonstrated protection against medically treated lower respiratory tract infections caused by RSV with a single dose during the RSV season
- If approved, Beyfortus would be the first fully protective option for newborns and infants
Paris, September 162022. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for Beyfortus® (nirsevimab) for the prevention of lower respiratory tract respiratory syncytial virus (RSV) disease in newborns and infants during their first RSV season. If approved, Beyfortus would be the first and only single-dose passive immunization regimen for the broad infant population, including those born healthy, term or preterm, or born with specific health conditions. Beyfortus is jointly developed by Sanofi and AstraZeneca.
Jean Francois Toussaint
Global Head of Vaccine Research and Development, Sanofi
“Today’s positive opinion from the CHMP is one of the most significant public health achievements at RSV in decades and has the potential to alleviate the tremendous physical and emotional burden that RSV can impose on families and healthcare systems. This endorsement brings us one step closer to our goal of protecting all infants from RSV with a single dose.”
Iskra Reik
Executive Vice President, Vaccines and Immunotherapies, AstraZeneca
“This positive CHMP opinion underlines the potential of Beyfortus as a first-in-class game changer passive immunization the could change the approach of the medical community RSV Prevention in Infants.”
The CHMP based its positive opinion on the results of Beyfortus’ clinical development programme, including the phase 3 studies MELODY, phase 2/3 MEDLEY and phase 2b.1-8th In the MELODY and Phase 2b studies, Beyfortus met its primary endpoint of reducing the incidence of medically assisted…
