Sotatercept

Merck announced positive Phase 3 ZENITH study results for WINREVAIR (sotatercept-csrk) in PAH, meeting primary endpoint of reducing morbidity/mortality risk. Study recommended for early termination, with participants offered WINREVAIR in an open-label extension. WINREVAIR is approved in the U.S. and 36 other countries, with Merck planning to present ZENITH results at a medical meeting and submit to regulatory authorities.

Merck announced positive Phase 3 ZENITH study results for WINREVAIR in PAH patients, meeting primary endpoint of time to first morbidity or mortality event. Study recommended to stop early; participants offered WINREVAIR. Second positive phase 3 trial adds to evidence for WINREVAIR as an activin signaling inhibitor therapy.

Winrevair (sotatercept-csrk) significantly reduced the risk of all-cause death, lung transplant, or hospitalization in a Phase 3 trial for PAH patients at high risk of dying, leading to an early trial conclusion. All participants are now offered Winrevair in the SOTERIA extension study.

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MSD's Phase III ZENITH trial of WINREVAIR (sotatercept-csrk) for pulmonary arterial hypertension (PAH) met its primary endpoint. The double-blind, placebo-controlled trial involved 172 PAH patients with high mortality risk. WINREVAIR, alongside standard PAH therapy, achieved the primary outcome of time to first morbidity or mortality event at interim analysis. Adverse events were similar across treatment and placebo groups. An independent data monitoring committee recommended early termination of the ZENITH study.

Merck announced positive Phase 3 ZENITH study results for WINREVAIR in PAH patients, demonstrating significant reduction in morbidity/mortality risk. The study met its primary endpoint, leading to early termination and offering WINREVAIR to participants. WINREVAIR is currently approved in the U.S. and 36 countries, with a submission for Japanese approval in November.

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