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

Core Viewpoint - Merck has received FDA approval for an updated product label for WINREVAIR, an activin signaling inhibitor, based on the Phase 3 ZENITH trial, indicating its efficacy in treating adults with pulmonary arterial hypertension (PAH) to improve exercise capacity [1] Group 1: Product Information - WINREVAIR is now FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH), classified as WHO Group 1 pulmonary hypertension [1] - The approved dosages for WINREVAIR are 45mg and 60mg for injection [1] Group 2: Clinical Trial - The approval is based on results from the Phase 3 ZENITH trial, which supports the product's effectiveness in improving exercise capacity for patients with PAH [1]