Merck & Co. Inc. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use $(CHMP)$ has recommended approval of an expanded indication for WINREVAIR™ (sotatercept) in combination with other therapies for the treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO Functional Class II, III, and IV. The recommendation is based on data from the Phase 3 ZENITH trial, which demonstrated a 76% reduction in the risk of major morbidity and mortality outcomes when WINREVAIR was added to background therapy compared to placebo in adults with PAH WHO functional class III or IV. The study's results, which led to early termination of the trial due to efficacy, have been published in the New England Journal of Medicine. The CHMP also considered morbidity and mortality data from the Phase 3 STELLAR trial. The CHMP recommendation will be reviewed by the European Commission, with a final decision expected in the first quarter of 2026.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Merck & Co. Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20251211664046) on December 12, 2025, and is solely responsible for the information contained therein.
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