Merck (MRK) has announced positive topline results from its Phase 3 ZENITH study, evaluating WINREVAIR (sotatercept-csrk) in adult patients with pulmonary arterial hypertension (PAH) functional class III or IV who are at high risk of mortality. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events compared to placebo, when added to background PAH therapy.
The ZENITH study focused on patients with PAH functional class III or IV, representing a population at heightened risk. The trial's success underscores the potential of WINREVAIR to address a critical unmet need in managing severe PAH.
Early Study Termination Recommendation
Based on the compelling efficacy data, an independent data monitoring committee recommended that the ZENITH study be stopped early. Furthermore, the committee advised that all participants be offered the opportunity to receive WINREVAIR through the SOTERIA open-label extension study. This decision reflects the significant benefit observed with WINREVAIR treatment.
WINREVAIR's Existing Approvals and Submissions
WINREVAIR is currently approved in the U.S. and 36 other countries, approvals which were based on the results from the Phase 3 STELLAR trial. In November, Merck submitted WINREVAIR for approval in Japan, supported by the STELLAR trial and data from an open-label Phase 3 study involving Japanese patients.
