- 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.
For further details see:
EMA panel backs approval of AstraZeneca/Sanofi's RSV preventing drug Beyfortus for infants