AstraZeneca’s Beyfortus recommended for approval in the EU by CHMP AstraZeneca plc (LON:AZN) and Sanofi''s Beyfortus (nirsevimab) has been recommended for marketing authorisation in the European Union (EU) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. If approved, Beyfortus would be the first and only single-dose passive immunisation for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Authority based its positive opinion on results from the Beyfortus clinical development programme, including the MELODY Phase III, MEDLEY Phase II|III, and Phase IIb trials. 1-8 In the MELODY and Phase IIb trials, Beyfortus met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections (LRTI) caused by RSV during the RSV season vs. placebo with a single dose. 1-6 No clinically meaningful differences in safety results between the Beyfortus and placebo groups were seen.