Merck says FDA approves updated indication for WINREVAIR

Merck (MRK) announced that the U.S. FDA has approved an update to the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR for injection, 45mg, 60mg. WINREVAIR, an activin signaling inhibitor, is now FDA-approved for the treatment of adults with pulmonary arterial hypertension to improve exercise capacity and WHO functional class, and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. WINREVAIR was initially approved based on the pivotal STELLAR study in March 2024. This approval expanded the indication of WINREVAIR to include components of the clinical worsening events: hospitalization for PAH, lung transplantation and death.