Merck Secures Positive CHMP Opinion to Expand WINREVAIR Use in PAH, Potentially Extending Treatment to WHO FC IV in Europe
SHERIDAN, WYOMING - December 19, 2025 - Merck said the EMA's CHMP has recommended approval of an expanded European indication for WINREVAIR (sotatercept) in adults with pulmonary arterial hypertension (PAH), a move that-if confirmed by the European Commission-could broaden use to include WHO Functional Class (FC) IV patients and strengthen the product's positioning around morbidity and mortality benefit.