Merck Gets CHMP Backing of Winrevair in Pulmonary Arterial Hypertension

By Colin Kellaher

Merck & Co. on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Winrevair for pulmonary arterial hypertension, or PAH.

The Rahway, N.J., drugmaker said the recommendation covers Winrevair in combination with other PAH therapies in adults with the potentially fatal lung disease.

The European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected in the third quarter.

The U.S. Food and Drug Administration in March approved Winrevair, which was the key drug in Merck's $11.5 billion acquisition of Acceleron Pharma in 2021 and is the subject of a licensing agreement with Bristol Myers Squibb.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

06-28-24 0733ET