Merck wins EC approval for Winrevair

27 August 2024

US pharma giant Merck & Co (NYSE: MRK) has announced that the European Commission (EC) has approved 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 is the first and only activin signaling inhibitor therapy for PAH approved in all 27 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

It works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH. The EC approval is based on safety and efficacy results from the Phase III STELLAR trial.

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