EMA panel backs approval of AstraZeneca/Sanofi's RSV preventing drug Beyfortus for infants
Waldemarus


A committee of the European Medicines Agency (EMA) recommended the approval of AstraZeneca (NASDAQ:AZN) and Sanofi's (NASDAQ:SNY) antibody Beyfortus in EU to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.
If approved by the European Commission, Beyfortus (nirsevimab) would be the first and only single-dose passive immunization for a broad infant population, including those born healthy, at term or preterm or with specific health conditions, the companies said in a Sept. 16 press release.

The positive opinion of the EMA's Committee for Medicinal Products for Human Use (CHMP) was backed by data from the phase 3 called MELODY, phase 2/3, dubbed MEDLEY, and phase 2b trials.
Under an agreement for Beyfortus, AstraZeneca leads all development and manufacturing activities while Sanofi will lead commercialization activities and record revenues.