Merck (MRK) said Friday the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Enflonsia (clesrovimab) to prevent respiratory syncytial virus lower respiratory tract disease in newborns and infants during their first RSV season.

The European Commission will review the recommendation, with a final marketing authorization decision expected before year-end for the European Union, Iceland, Liechtenstein, and Norway.