Merck's WINREVAIR Reduces PAH Clinical Worsening Risk by 76% in Phase 3 Trial
- WINREVAIR reduced clinical worsening events by 76% in PAH patients.
- The Phase 3 HYPERION trial included patients diagnosed within the past year.
- Over 70% of participants were on double background therapy.
- Results were presented at ERS 2025 and published in NEJM.
Study Overview
Merck announced positive results from the Phase 3 HYPERION trial, evaluating WINREVAIR (sotatercept-csrk) against placebo in adults with pulmonary arterial hypertension (PAH), WHO Group 1, functional class II or III, at intermediate or high risk of disease progression.
Key Findings
WINREVAIR reduced the risk of clinical worsening events by 76%, with a hazard ratio of 0.24 and a 95% confidence interval of 0.14 to 0.41, achieving a p-value of less than 0.0001. The composite endpoint included all-cause death, non-planned PAH-related hospitalization, atrial septostomy, lung transplantation, or PAH deterioration.
Participant Details
The trial included participants diagnosed within the first year, with a median diagnosis time of seven months, and as early as one month. Over 70% of participants were on double background therapy.
Safety Profile
The safety profile of WINREVAIR was generally consistent with previous trials.
Publication and Presentation
Results were presented at the 2025 European Respiratory Society Congress and simultaneously published in the New England Journal of Medicine.
Source: Merck