Merck's Phase 3 HYPERION Study Of Winrevair Meets Primary Goal

(RTTNews) - Merck & Co Inc. (MRK) Monday announced positive topline results from the Phase 3 HYPERION study evaluating Winrevair in adults with recently diagnosed pulmonary arterial hypertension (PAH). The study met its primary goal.

The HYPERION study is designed to evaluate Winrevair when added to background PAH therapy versus placebo in newly diagnosed intermediate or high-risk PAH patients. The primary endpoint of the study was time to clinical worsening (TTCW), the need for non-planned PAH-related hospitalization for more than 24 hours, atrial septostomy, lung transplantation, or PAH deterioration.

Winrevair is alredy approved by the FDA for the treatment of adults with PAH to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events.