Merck Secures Updated Label for WINREVAIR After Positive HYPERION Trial Results

Merck has received FDA approval for an updated U.S. label for its treatment WINREVAIR (sotatercept-csrk) based on Phase 3 HYPERION trial data.

The updated label adds efficacy and safety information for newly diagnosed pulmonary arterial hypertension (PAH) patients receiving background therapy.

The HYPERION trial showed a significant reduction in clinical worsening events, with a 76% decrease compared to placebo.

WINREVAIR is approved to improve exercise capacity and WHO functional class while reducing the risk of clinical worsening events, including PAH-related hospitalization, lung transplantation, and death.