Merck's WINREVAIR Receives CHMP Recommendation For Expanded PAH Indication Covering WHO FC II–IV

Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of an expanded indication for WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III, and IV based on the Phase 3 ZENITH study. The currently approved indication in the European Union (EU) is for adults with PAH with WHO FC II to III, to improve exercise capacity. The CHMP recommendation will now be reviewed by the European Commission (EC) for amending the marketing authorization in the EU, Iceland, Liechtenstein and Norway, and a final decision is expected in the first quarter of 2026.