FDA accepts new supplemental biologics license application for review for Winrevair

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with advanced pulmonary arterial hypertension, according to a press release from Merck.

According to the release, data from the phase 3 ZENITH trial assessing Winrevair (sotatercept, Merck) in 172 adults with WHO functional class III or IV PAH and a high 1-year risk for death already receiving maximally tolerated background therapy support the supplemental biologics license application.

Researchers presented the multicenter, double-blind, randomized, placebo-controlled ZENITH trial results at the 2025 American College of Cardiology Scientific Session, and the data were published in The New England Journal of Medicine.

As Healio previously reported, researchers uncovered an incidence of at least one component of the primary endpoint (all-cause death, lung transplantation or PAH hospitalization, all starting 24 hours from treatment initiation) in 17.4% of the Winrevair group and 54.7% of the placebo group, which translated to a hazard ratio of 0.24 (95% CI, 0.13-0.43; P < .0001).

Notably, this trial was ended early due to strong efficacy data reported during an interim analysis in November.

“The FDA’s priority review designation acceptance of our supplemental biologics license application reinforces our confidence in Winrevair for a broad range of patients and represents a critical step toward advancing the treatment of PAH,” Joerg Koglin, MD, PhD, senior vice president of global clinical development at Merck Research Laboratories, said in the release.

Since the FDA has already approved Winrevair for treating adults with PAH based, in part, on data from the phase 3 STELLAR trial, Merck wrote that this approval would allow them to update Winrevair’s product label.

The company anticipates an FDA response by Oct. 25.