Merck’s WINREVAIR Receives EU Approval for Pulmonary Arterial Hypertension Treatment

EU Approval:
The European Commission has approved WINREVAIR (sotatercept) for the treatment of pulmonary arterial hypertension (PAH) in adult patients with World Health Organization (WHO) Functional Class II to III, to improve exercise capacity.

First-in-Class Therapy:
WINREVAIR is the first activin signaling inhibitor therapy approved for PAH in Europe, offering a new treatment option for eligible adults.

Clinical Trial Results:
The approval is based on the Phase 3 STELLAR trial, which demonstrated a statistically significant and clinically meaningful improvement in 6-minute walk distance and reduced the risk of death or clinical worsening events.

Administration:
WINREVAIR is administered once every 3 weeks as a single injection under the skin and can be given by patients or caregivers with proper training and follow-up from a healthcare provider.

Global Approvals:
WINREVAIR was previously approved by the U.S. Food and Drug Administration (FDA) in March 2024 for similar indications.

Merck's Commitment:
The approval highlights Merck's focus on expanding access to innovative treatments for patients with PAH and its commitment to addressing unmet medical needs in this area.