The European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has recommended expanding WINREVAIR™ (sotatercept) approval for pulmonary arterial hypertension (PAH) treatment to include World Health Organisation (WHO) Functional Class II, III, and IV patients (previously only II-III). The recommendation is based on the Phase 3 ZENITH trial, which showed a 76% reduction in risk of major morbidity and mortality outcomes. The European Commission is expected to make a final decision in Q1 2026. WINREVAIR is the first and only activin signaling inhibitor approved for pulmonary arterial hypertension and is currently available in over 50 countries. It received expanded Food and Drug Administration (FDA) approval in the USA in October 2025.
Read more on the Merck press release at this link