Merck wins EU nod for rare lung disease drug Winrevair

Merck ( NYSE: MRK ) has received approval from the European Commission for its drug Winrevair (sotatercept), to be used in combination with other pulmonary arterial hypertension (PAH) therapies. Winrevair is indicated for treatment of PAH, a rare lung disease, in adults to improve exercise capacity. It is the first and currently only activin signaling inhibitor therapy for PAH approved in the EU.

The drug works by regulating vascular cell proliferation underlying PAH. This marks the full approval of the drug after it received Priority Medicines and orphan designation by the European Medicines Agency (EMA) for PAH treatment. Winrevair received U.

S. approval earlier this year. In June, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval for the drug.

It is estimated that about 40K and 30K people in the U.S. and EU suffer from PAH, a rare blood vessel-related disorder that leads to elevated blood pressure in the lungs and related structures.

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