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U.S. FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension) Based on Phase 3 ZENITH Study
RAHWAY, N.J., October 27, 2025--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved 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
About this update from Merck & Company, Inc.
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