KENILWORTH (NJ) (dpa-AFX) - Merck & Co., Inc. (MRK), known as MSD outside of the U.S. and Canada, announced Monday positive topline results from the Phase 3 ZENITH study evaluating WINREVAIR (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH) functional class (FC) III or IV at high risk of mortality.
ZENITH met its primary endpoint of time to first morbidity or mortality event for the treatment of patients with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality.
In the study, WINREVAIR demonstrated a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events compared to placebo, both on top of background PAH therapy.
Based on the strength of these results, an independent data monitoring committee has recommended ZENITH be stopped early and all participants be offered the opportunity to receive WINREVAIR through the SOTERIA open-label extension study.
WINREVAIR is currently approved in the U.S. and 36 countries based on the results from the Phase 3 STELLAR trial. Most recently, in November of this year, WINREVAIR was submitted for approval in Japan based on the STELLAR trial and results from an open-label Phase 3 study in Japanese patients.
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