Merck Makes Strong Case for Winrevair in Earlier-Stage Pulmonary Arterial Hypertension (PAH) Patients After Positive Phase 3 HYPERION Results

Merck announced positive topline results from the Phase 3 HYPERION trial, showing that Winrevair (sotatercept-csrk) significantly reduced the risk of clinical worsening events by 76% compared to placebo in recently diagnosed PAH patients134.

Clinical worsening was defined as a composite endpoint including all-cause death, non-planned PAH-related hospitalizations (>24 hours), atrial septostomy, lung transplantation, or PAH deterioration13.

Over 70% of trial participants were receiving double background therapy, indicating Winrevair’s benefit even in patients already on significant PAH treatment1.

The HYPERION results expand Winrevair’s evidence base to include patients earlier in their PAH disease journey, supporting its use beyond those several years into treatment1.

Winrevair is a first-in-class activin signaling inhibitor—the first approved drug for PAH that targets this pathway, restoring balance to vascular proliferation and improving blood flow2.

The safety profile of Winrevair in the HYPERION study was consistent with previous trials, with similar rates of adverse and serious adverse events compared to placebo3.

Winrevair received FDA approval for PAH in March 2024 and is approved in over 45 countries based on previous pivotal trials21.

The HYPERION trial was stopped early due to efficacy observed in earlier data review, and Merck plans to present the full results at a future medical meeting and submit data to regulators1.

Sources:

1. https://www.merck.com/news/merck-announces-phase-3-hyperion-study-of-winrevair-sotatercept-csrk-met-primary-endpoint-in-recently-diagnosed-adults-with-pulmonary-arterial-hypertension-pah/

2. https://www.biospace.com/drug-development/mercks-winrevair-cuts-morbidity-mortality-risk-by-over-75-in-phase-iii-pah-study

3. https://www.benzinga.com/news/health-care/25/09/47941657/mercks-winrevair-cuts-clinical-worsening-risk-by-76-among-hypertension-patients

4. https://www.fiercepharma.com/pharma/merck-unveils-data-winrevair-study-which-was-halted-efficacy