Merck has announced positive topline results from the Phase 3 ZENITH study evaluating WINREVAIR (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH). The study met its primary endpoint of reducing the risk of morbidity or mortality events compared to placebo.
 
Based on these results, an independent data monitoring committee recommended early termination of the study, and all participants will be offered access to WINREVAIR through an open-label extension study. Adverse events were balanced between treatment groups.
 
These findings are impressive, set a high evidentiary bar for studies of future candidates developed for the treatment of PAH and support the potential of WINREVAIR to be practice-changing in the management of PAH,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
 
WINREVAIR is already approved in the U.S. and 36 other countries. Merck plans to present the ZENITH results at an upcoming medical meeting and submit them to regulatory authorities.