Merck Receives Positive EU CHMP Opinion for Expanded Use of WINREVAIR™ (sotatercept) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension)
MerckMerck(US:MRK) Businesswire·2025-12-12 13:45

Core Viewpoint - Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of an expanded indication for WINREVAIR™ (sotatercept) for treating pulmonary arterial hypertension (PAH) in adult patients [1] Group 1: Product Information - WINREVAIR™ (sotatercept) is recommended for use in combination with other PAH therapies [1] - The recommendation is based on the results of the Phase 3 ZENITH study [1] Group 2: Patient Population - The expanded indication targets adult patients with WHO Functional Class (FC) II, III, and IV [1]