RSV antibody from Sanofi and AstraZeneca approved in Europe

(Chemical and Engineering News) With the first vaccines to guard against respiratory syncytial virus (RSV) expected to receive regulatory approval in the months ahead, the European Commission earlier this month gave its nod to a monoclonal antibody developed by Sanofi and AstraZeneca to prevent RSV lower respiratory tract illness (LRTI) in newborns and infants. The EC’s approval of the drug, Beyfortus (nirsevimab), is based on a series of clinical trials, including Phase 3 trials, and follows the recommendation in September of the European Medicines Agency’s Committee for Medicinal Products for Human Use.