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Merck (NYSE:MRK) announced on Friday that a panel of the European Medicines Agency (EMA), the EU’s drug regulator, approved its lung disease treatment Winrevair in combination with other drugs to treat certain adults with pulmonary arterial hypertension (PAH).
EMA committee The Committee for Medicinal Products for Human Use (CHMP) issued a so-called positive opinion recommending approval of the drug, also known as sotatercept, from Merck & Co. (MRK) was added as part of the $11.5B acquisition of Acceleron in 2021.
The European Commission (EC) will next review the CHMP recommendations before making a final decision on marketing authorization, expected in the third quarter of 2024, the company said.
An estimated 40,000 people in the United States and 30,000 people in the European Union suffer from PAH, a rare blood vessel-related disease that causes elevated blood pressure in the lungs and related structures. In March this year, the US FDA approved Winrevair for the same indication.
