The European Commission (EC) has granted approval to Merck & Co’s (MSD) Winrevair (sotatercept) to be used as a combination therapy for the treatment of adults with functional class II or III pulmonary arterial hypertension (PAH).

The approval was awarded based on data from STELLAR, a Phase III study (NCT04576988) that evaluated 323 adult participants with functional class II or III PAH, as determined by the World Health Organization (WHO), as per the 26 August press announcement,

The European approval for the subcutaneously administered therapy follows one from the US Food and Drug Administration (FDA) in March 2024 for the same group of PAH patients. According to GlobalData’s consensus forecasts, Winrevair is expected to generate total sales of $6.3bn in 2030. GlobalData is the parent company of Pharmaceutical Technology.

Notably, a day before the approval of Winrevair, the FDA granted approval to Johnson & Johnson’s (J&J) Opsynvi (macitentan + tadalafil). Opsynvi is approved to treat adult patients with WHO Group 1 and functional classes II and III PAH.

According to study results published in the New England Journal of Medicine, Winrevair demonstrated a median change in 6-minute walk distance (6MWD) from baseline of 34.4m, which was superior to the 1.0m with placebo at 24 weeks, the study’s primary efficacy endpoint. While the number of reported adverse events was similar in the treatment and placebo groups (138 vs. 140), participants receiving Winrevair experienced more frequent cases of epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure.

Winrevair is a first-in-class activin signaling inhibitor designed to increase exercise capacity by binding to several TGF beta superfamily ligands and blocking their signals that contribute to the progression of PAH. As the first approved PAH therapy targeting the activin signaling pathway, the EC approval of Winrevair is an “important step for patients,” said Dr. Joerg Koglin, MSD senior VP and head of general medicine, global clinical development at Merck Research Laboratories. MSD is committed to further investigation of Winrevair in areas of “unmet needs in the management of PAH,” Koglin added.

PAH is a rare, blood vessel disorder characterised by the narrowing of the small blood vessels in an individual’s lungs, which results in high blood pressure (hypertension) in the pulmonary artery.

MSD is one of several companies developing treatments for PAH. In 2023, GlobalData tracked 129 drugs in development for PAH, nine of which were under development by institutes and universities.

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