AstraZeneca, Sanofi respiratory drug gets EU marketing go-ahead
AstraZeneca and Sanofi said their Beyfortus drug for the prevention of lower respiratory tract disease in newborns and infants has been recommended for marketing authorisation in the European Union
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 respiratory syncytial virus during the RSV season against a placebo with a single dose, AstraZeneca said in a statement on Friday.