US pharmaceutical company Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, announced on Monday that it has secured European Commission approval for WINREVAIR (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, as a treatment for PAH in adult patients with WHO Functional Class II-III.

WINREVAIR, the first activin signalling inhibitor therapy for PAH in Europe, improves exercise capacity when combined with other PAH therapies.

The approval is based on data from the Phase 3 STELLAR trial, which demonstrated significant improvements in six-minute walk distance and reduced the risk of death or clinical worsening compared to placebo.

WINREVAIR is administered as a subcutaneous injection once every three weeks and is approved in all 27 EU member states, as well as Iceland, Liechtenstein and Norway.