Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of WINREVAIR (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with World Health Organization (WHO) functional Class (FC) II to III, to improve exercise capacity. WINREVAIR was previously granted Priority Medicines (PRIME) and orphan designation by the EMA for the treatment of PAH. The CHMP recommendation is based on data from the Phase 3 STELLAR trial of WINREVAIR on top of background PAH therapy compared to background therapy alone.

WINREVAIR demonstrated a statistically significant and clinically meaningful improvement in 6-minute walk distance, the study's primary endpoint, and on multiple important secondary outcome measures, including reducing the risk of death from any cause or PAH clinical worsening events. These results were published in The New England Journal of Medicine. Through the CHMP recommendation, the EMA is the second regulatory body to recognize the potential of WINREVAIR in the treatment of PAH based on a review of pivotal efficacy and safety data.

In March 2024, WINREVAIR (sotatercept-csrk) was approved by the U.S. Food and Drug Administration (FDA).