Merck, known as MSD outside of the US and Canada, announced on August 26, 2024 that the European Commission has approved WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of pulmonary arterial hypertension in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, to improve exercise capacity.
WINREVAIR is the first and only activin signaling inhibitor therapy for pulmonary arterial hypertension approved in all 27 member states of the EU, as well as Iceland, Liechtenstein and Norway. WINREVAIR works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying pulmonary arterial hypertension. The European Commission approval is based on safety and efficacy results from the Phase 3 STELLAR trial.
Read more on the Merck press release at this link
Sotatercept was approved by the US Food and Drug Administration (FDA) on March 26, 2024.
