The U.S. Food and Drug Administration (FDA) has accepted and granted priority review for Merck & Co. Inc.’s 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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The ZENITH trial was the first PAH Phase 3 outcome study to use a primary endpoint comprised entirely of major morbidity and mortality events.
It was also the first PAH Phase 3 study stopped early by an independent data monitoring committee for overwhelming efficacy.
In ZENITH, Winrevair demonstrated a 76% reduction in the risk of a composite of all-cause death, lung transplantation, and hospitalization for PAH ≥24 hours compared to placebo. Improvement was observed early in treatment with increasing benefit throughout the study.
The safety profile of Winrevair in ZENITH was generally consistent with that observed in previous studies. These results were published in the New England Journal of Medicine. Winrevair is currently approved in more than 45 countries based on the results from the STELLAR trial.
In June, Merck released topline results from the Phase 3 HYPERION study evaluating Winrevair versus placebo (both in combination with background therapy) in recently diagnosed adults with PAH functional class (FC) II or III at intermediate or high risk of disease progression.
HYPERION met its primary endpoint of time to clinical worsening (TTCW) as measured by a composite endpoint of all-cause death, the need for non-planned PAH-related hospitalization > 24 hours, atrial septostomy, lung transplantation, or PAH deterioration.
In HYPERION, Winrevair added on top of background therapy (72.2% of patients on double therapy) within 12 months after initial diagnosis of PAH demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events compared to placebo.
Price Action: MRK stock is trading higher by 0.39% to $82.13 at last check Wednesday.
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