WINREVAIR (sotatercept) has been approved by the European Commission for the treatment of pulmonary arterial hypertension (PAH) in adult patients with World Health Organization (WHO) Functional Class II to III. Merck, which is known as MSD outside the United States and Canada, made the announcement on August 26, 2024. WINREVAIR is the first activin signaling inhibitor therapy approved for PAH across the EU and other European nations, including Iceland, Liechtenstein, and Norway. The approval is based on results from the Phase 3 STELLAR trial, which demonstrated WINREVAIR's efficacy in improving exercise capacity and reducing the risk of clinical worsening compared to placebo.
WINREVAIR functions by enhancing the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation, a key factor in PAH pathology. Administered every three weeks via subcutaneous injection, WINREVAIR showed a statistically significant improvement in six-minute walk distance and a substantial reduction in death or clinical worsening events in the STELLAR trial. Merck continues to focus on advancing treatments for PAH and is committed to exploring further applications of WINREVAIR to address unmet needs in this challenging condition.
