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Merck (NYSE:MRK) announced Friday that an expert panel of the EU drug regulator, the European Medicines Agency (EMA), endorsed its lung disease therapy Winrevair in combination with other medications for certain adults with pulmonary arterial hypertension (PAH).
EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a so-called positive opinion recommending approval for the drug, also known as sotatercept, which Merck (MRK) added as part of its $11.5B acquisition of Acceleron in 2021.
The CHMP recommendation will next be reviewed by the European Commission (EC) before a final decision on marketing authorization, expected in Q3 2024, the company said.
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. In March, the U.S. FDA approved Winrevair for the same indication.