Merck says FDA grants priority review for WINREVAIR to update label

Merck (MRK) announced that the U.S. FDA has accepted and granted priority review for a new supplemental Biologics License Application seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR. In 2024, WINREVAIR was approved for the treatment of adults with pulmonary arterial hypertension to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events. The FDA has set a Prescription Drug User Fee Act, or target action date, of Oct. 25, 2025.