Merck, also known as MSD outside of the United States and Canada, has announced the FDA approval of Winrevair™ (sotatercept), a groundbreaking biologic for the treatment of adults with pulmonary arterial hypertension (PAH). This new therapy, administered by injection, is designed to increase exercise capacity, improve functional class, and reduce the risk of clinical worsening events in PAH patients.

Winrevair represents a significant advancement in PAH treatment as the first FDA-approved activin signaling inhibitor therapy for this condition. By modulating vascular cell proliferation, Winrevair targets a new and fourth pathway in PAH treatment, offering hope to patients where traditional therapies may have fallen short.

The approval of Winrevair follows positive results from the Phase 3 Stellar trial, which demonstrated significant clinical benefits compared to standard background therapy alone. Patients receiving Winrevair experienced a notable increase in exercise capacity, improvement in functional class, and a reduction in the risk of death or PAH clinical worsening events.

Winrevair is administered once every three weeks via subcutaneous injection and is expected to be available through select specialty pharmacies in the U.S. by the end of April.

Additionally, the European Medicines Agency (EMA) is currently evaluating Winrevair for approval in EU member states and in EEC countries.