Posted by Michael Wonder on 27 Oct 2025
US FDA approves updated indication for Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (WHO Group 1 pulmonary hypertension) based on Phase 3 ZENITH study
27 October 2025 - Merck today announced that the US FDA has approved an update to the US product label based on the Phase 3 ZENITH trial for Winrevair (sotatercept-csrk) for injection, 45 mg, 60 mg.
Winrevair, an activin signaling inhibitor, is now FDA approved for the treatment of adults with pulmonary arterial hypertension (WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class, and reduce the risk of clinical worsening events, including hospitalisation for pulmonary arterial hypertension, lung transplantation and death.
