PHA Europe is pleased to share the exciting news that the European Medicines Agency (EMA) has approved WINREVAIR™ (sotatercept) for the treatment of Pulmonary Arterial Hypertension (PAH). This approval marks a significant milestone as WINREVAIR becomes the first activin signaling inhibitor therapy for PAH to be approved in Europe.

WINREVAIR is designed to be used in combination with other PAH therapies for adult patients in WHO Functional Class II to III, with the primary goal of improving exercise capacity. The approval by the European Commission covers all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.

This approval is based on the robust results from the Phase 3 STELLAR trial, where WINREVAIR demonstrated a statistically significant and clinically meaningful improvement in the six-minute walk distance compared to placebo. Additionally, the drug significantly reduced the risk of death or clinical worsening events when added to background PAH therapies.

WINREVAIR is administered once every three weeks as a subcutaneous injection, offering a convenient treatment option for patients. This innovation not only represents a new standard of care but also brings hope to PAH patients across Europe who have long awaited new treatment options.

The approval of WINREVAIR in Europe follows its approval by the FDA in March 2024 for the treatment of PAH in the United States. With this new treatment option, there is optimism for better management of PAH, improved patient outcomes, and enhanced quality of life for those affected by this challenging condition.

PHA Europe looks forward to the positive impact this therapy will have on the PAH community and will continue to support initiatives that advance the care and treatment of PAH patients.