Merck's WINREVAIR Gets FDA Priority Review for Pulmonary Arterial Hypertension
Merck, also known as MSD outside the U.S. and Canada, announced that the FDA has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) for WINREVAIR (sotatercept-csrk). The application seeks to update the drug’s U.S. label based on findings from the Phase III ZENITH trial in pulmonary arterial hypertension (PAH, Group 1 PH). The FDA has set the Prescription Drug User Fee Act (PDUFA) action date for October 25, 2025.
In the ZENITH trial, WINREVAIR showed a 76% reduction in the risk of a composite of all-cause death, lung transplantation, or PAH-r...
