Merck's Hypertension Drug On FDA Fast Track For Label Expansion

The U.S. Food and Drug Administration (FDA) has accepted and granted priority review for Merck & Co. Inc.’s (NYSE:MRK) new supplemental Biologics License Application (sBLA) seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for Winrevair (sotatercept-csrk).

In 2024, Winrevair was approved for adults with pulmonary arterial hypertension (PAH, Group 1 PH) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of October 25. The supplemental marketing application is based on Phase 3 ZENITH trial data.

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