Sector News

Sanofi, AstraZeneca win EMA support for RSV drug in babies

September 17, 2022
Life sciences

The European Union’s drug regulator has recommended approval of AstraZeneca and Sanofi’s Beyfortus to prevent respiratory syncytial virus infection in newborns and babies, the companies said Friday. The antibody drug would be the first to be used broadly in those children.

Beyfortus is recommended as a preventive treatment for babies in their first RSV season, which like for colds and influenza runs from late autumn through spring. The drug is given as a single injection and, the companies report, reduced RSV infections requiring medical attention by 75% compared to a placebo in a Phase 3 trial.

The recommendation from the European Medicines Agency’s human drugs committee needs to be confirmed by the European Commission, which has two months to do so. READ MORE

By Jonathan Gardner



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