Rahway: Merck, known as MSD outside the United States and Canada, has announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for an update to the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR (sotatercept-csrk) for injection, 45mg, 60mg.

WINREVAIR, an activin signaling inhibitor, is now FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), 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. The approval expanded the indication of WINREVAIR to include co

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