Merck Touts Data in Pulmonary Arterial Hypertension

Merck says data from its Phase 3 ZENITH trial showed that Winrevair (sotatercept-csrk) significantly reduces the risk of major morbidity and mortality events in adults with pulmonary arterial hypertension. The findings prompted an independent data monitoring committee to recommend early termination of the trial due to overwhelming efficacy, according to the company. Participants were subsequently offered the opportunity to continue treatment in the open-label SOTERIA extension study.

According to the data, Winrevair demonstrated a 76% reduction in the relative risk of major morbidity and mortality events compared to placebo, Merck says. Among patients receiving Winrevair, 17.4% experienced one or more major morbidity and mortality events compared with 54.7% of patients taking a placebo, it says, adding that the drug’s safety profile was generally consistent with that observed in previous studies.

The company says global regulatory submissions are underway.