- CHMP recommends expanded use of WINREVAIR™ for PAH in adults with WHO FC II-IV.
- European Commission decision expected in Q1 2026.
- Phase 3 ZENITH trial showed 76% reduction in morbidity and mortality risk.
- WINREVAIR™ is approved in over 50 countries.
CHMP Recommendation
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the use of WINREVAIR™ (sotatercept) for treating pulmonary arterial hypertension (PAH) in adults with WHO Functional Class II, III, and IV. This recommendation is based on the Phase 3 ZENITH study.
European Commission Review
The CHMP's recommendation will be reviewed by the European Commission for potential amendment of the marketing authorization in the EU, Iceland, Liechtenstein, and Norway. A final decision is anticipated in the first quarter of 2026.
Phase 3 ZENITH Trial Results
The ZENITH trial demonstrated a 76% reduction in the risk of major morbidity and mortality outcomes for adults with PAH WHO functional class III or IV when WINREVAIR was added to background therapy. The trial's primary endpoint included time to first occurrence of all-cause death, lung transplantation, or PAH-worsening hospitalization of 24 hours or more.
Regulatory Status
WINREVAIR is the first and only activin signaling inhibitor therapy for PAH approved in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. It is currently approved in over 50 countries. In October 2025, the U.S. FDA approved an updated indication for WINREVAIR based on the Phase 3 ZENITH trial.
