Merck's WINREVAIR Shows Positive Phase 3 Results in PAH

Merck, known as MSD outside the U.S. and Canada, has announced positive topline results from its Phase 3 HYPERION study evaluating WINREVAIR (sotatercept-csrk) in combination with background therapy, compared to placebo, for pulmonary arterial hypertension (PAH) in recently diagnosed adults. The study successfully met its primary endpoint of time to clinical worsening (TTCW), a composite measure that includes all-cause death, non-planned PAH-related hospitalization over 24 hours, atrial septostomy, lung transplantation, or PAH deterioration.

Dr. Vallerie McLaughlin, Kim A Eagle MD Endowed Professor of Cardiovascular Medicine and Director, Pulmonary Hypertension Program at the University of Michigan, emphasized the importance of early intervention, stating, “PAH is a progressive and debilitating disease with a poor prognosis that can be difficult to diagnose and treat. Patients often struggle for years to find a treatment plan that helps manage the disease, so it’s critical to provide new options earlier in the treatment journey.”

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Dr. Joerg Koglin, Senior Vice President, Global Clinical Development, Merck Research Laboratories, highlighted, “To date, the strong clinical profile of WINREVAIR, a first-in-class activin signaling inhibitor, had been primarily established through previous studies in a prevalent patient population. These positive results from HYPERION expand on the body of clinical evidence now including recently diagnosed adults, supporting the practice-changing potential of WINREVAIR.”

The results will be presented at an upcoming medical meeting and submitted to regulatory authorities. WINREVAIR is already approved in over 45 countries based on the STELLAR study.