- Merck's Phase 3 HYPERION study of WINREVAIR™ shows positive results for pulmonary arterial hypertension (PAH) treatment.
- WINREVAIR significantly reduces the risk of clinical worsening in PAH patients, with a notable impact among those on double background therapy.
- HYPERION study results to be presented at a future medical meeting, with regulatory submissions forthcoming.
Merck (MRK, Financial), known as MSD outside the United States and Canada, announced promising top-line results from the Phase 3 HYPERION study evaluating WINREVAIR™ (sotatercept-csrk) for the treatment of newly diagnosed adults with pulmonary arterial hypertension (PAH). The study achieved its primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of clinical worsening events when compared to placebo.
The HYPERION study is the third Phase 3 clinical trial verifying the efficacy of WINREVAIR, with prior studies including STELLAR and ZENITH. Unlike previous trials, HYPERION involved a majority of participants on double therapy, adding valuable data on recent PAH diagnoses. A review of interim data from these trials prompted the early conclusion of the HYPERION study, moving to final analysis.
During the trial, WINREVAIR was administered on top of existing background PAH therapies, demonstrating its potential to improve treatment outcomes. Key improvements noted include reduced clinical worsening events, defined as all-cause death, unplanned PAH-related hospitalizations, atrial septostomy, lung transplantation, or PAH deterioration. Additionally, the safety profile remained consistent with previous studies.
The results signify a critical advancement in PAH treatment, offering optimism for patients and healthcare providers by providing new therapeutic possibilities earlier in the disease management process. These findings will be presented at an upcoming medical meeting later this year and submitted for regulatory approval, promising further expansion of WINREVAIR's availability in global markets.
WINREVAIR, approved in over 45 countries, is designed to increase exercise capacity and improve WHO functional class among PAH patients. As a first-in-class activin signaling inhibitor, it showcases potential practice-changing benefits across a broad spectrum of PAH cases.
