07:19 AM EDT, 07/02/2025 (MT Newswires) -- Merck ( MRK ) said Wednesday the US Food and Drug Administration has accepted and granted priority review to a new supplemental biologics license application for Winrevair.

The company said the drug was approved last year for adults with pulmonary arterial hypertension to increase exercise capacity and reduce the risk of clinical worsening events.

The drugmaker said the health agency's decision was based on a phase 3 trial that showed Winrevair reduced the risk of a composite of all-cause death, lung transplantation, and hospitalization for pulmonary arterial hypertension by 76% compared to placebo.

The FDA has set a Prescription Drug User Fee Act, or target action date, of Oct. 25.