MSD’s Winrevair Significantly Reduces Clinical Worsening in Early PAH

MSD announced positive Phase III HYPERION trial results for Winrevair (sotatercept-csrk) in adults with recently diagnosed pulmonary arterial hypertension (PAH). Administered alongside background therapy, Winrevair reduced clinical worsening events by 76% compared to placebo, with 10.6% of treated patients experiencing at least one event versus 36.9% in the placebo group.

The trial enrolled WHO Group 1, functional class II or III patients within their first year of diagnosis, with over 70% on double background therapy. The hazard ratio was 0.24 for a composite endpoint including mortality, PAH-related hospitalisation, atrial septostomy, lung transplantation, or disease deterioration.

Kaplan-Meier curves showed early and sustained separation, with benefits evident within six weeks. Effects were consistent across idiopathic PAH, connective tissue disease, double or triple background therapy, and intermediate-risk subgroups, reinforcing Winrevair’s potential in newly diagnosed patients.

01-10-2025