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Merck Receives Positive EU CHMP Opinion for Expanded Use of WINREVAIR™ (sotatercept) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension)
RAHWAY, N.J., December 12, 2025--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of an expanded indication for WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III, and IV based on the Phase 3 ZENITH study. The cu
About this update from Merck & Company, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":217,"url":"https://media.zenfs.com/en/business-wire.com/f7a2532829128065e2649a2fe11297f6"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/_s3EhmWSJUMtwYdwm5AOBw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQzNDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/f7a2532829128065e2649a2fe11297f6","width":480,"height":217}},"lazy":false},{"type":"text","content":"RAHWAY, N.J., December 12, 2025--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of an expanded indication for WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III, and IV based on the Phase 3 ZENITH study. The currently approved indication in the European Union (EU) is for adults with PAH with WHO FC II to III, to improve exercise capacity. The CHMP recommendation will now be reviewed by the European Commission (EC) for amending the marketing authorization in the EU, Iceland, Liechtenstein and Norway, and a final decision is expected in the first quarter of 2026.","length":874,"tagName":"p"},{"type":"text","content":""If approved, this broader indication would recognize the impact of WINREVAIR on morbidity and mortality in adult patients with PAH, extending the overall use of WINREVAIR to be inclusive of WHO FC II, III and now IV patients, with a treatment objective beyond the improvement of exercise capacity," said Dr. Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories. "We look forward to the EC's decision as we work to ensure broad patient access to the first and only activin signaling inhibitor therapy approved in Europe and continue to deliver meaningful evidence to support treatment decisions."","length":690,"tagName":"p"},{"type":"text","content":"The CHMP recommendation is based on data from the Phase 3 ZENITH trial which demonstrated that adding WINREVAIR to background therapy resulted in a statistically significant and clinically...