Merck Receives Positive EU Chmp Opinion for Expanded Use of Winrevair?? (Sotatercept) in Adults with Pulmonary Arterial Hypertension (Pah, Who* Group 1 Pulmonary Hypertension)

Merck 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.

WINREVAIR is the first and only activin signaling inhibitor therapy for PAH approved in all 27 member states of the EU, as well as Iceland, Liechtenstein and Norway, and is currently approved in more than 50 countries. In October 2025, the U.S. Food and Drug Administration (FDA) approved an updated indication based on the Phase3 ZENITH trial. WINREVAIR is now approved in the U.S. for the treatment of adults with PAH (WHO Group 1 pulmonary hypertension [PH) to improve exercise capacity and WHO FC, and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death.

The ZENITH study (NCT04896008) was a global, double-blind, placebo-controlled, multicenter, parallel-group clinical trial in which 172 adult participants with PAH (WHO FC III or IV) at high risk of mortality were randomized in a 1:1 ratio to either WINREVAIR (target dose 0.7 mg/kg) (n=86) plus background PAH therapy or placebo (n=86) plus backgrounds PAH therapy administered subcutaneously once every 3 weeks. The most common PAH etiologies were idiopathic PAH (50%), PAH associated with connective tissue diseases (CTD) (28%), and heritable PAH (11%). There were more participants in WHO FC III (74%) compared to WHO FC IV (26%).

The REVEAL Lite 2 risk score was ?? (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg In the U.S., WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PA H,WHO Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical improving events, including hospitalization forPAH, lung transplantation and deaths. WINREVAIR is The first activin signaling inhibitor therapy approved to treat PAH.

Advise patients on the potential effects on fertility. The most common adverse reactions (10% for WINREVAIR and at least 5% more than placebo) occurring in the STELLAR Phase 3 clinical trial were headache (24.5% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.3%) and erythema (13.5% vs 3.1%). The most common adverse reactions in the ZENITH trial were infections (67.4% vs 44.2%), epistaxis (45.3% vs 9.3%), diarrhea (25.6 % vs 17.4%), telangiectasia,25.6 % vs 3.5%), increased hemoglobin (15.1% vs 1.2%),ash (10.5% vs 4.7%), erythema (10.5%) and gingival bleeding (10.5% vs 2.3%).

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