07:23 AM EDT, 08/26/2024 (MT Newswires) -- Merck ( MRK ) said Monday that the European Commission has approved Winrevair, in combination with other therapies for pulmonary arterial hypertension or PAH, to treat PAH and improve exercise capacity in adults with World Health Organization Functional Class II to III.
The company said the approval was based on the results of a phase 3 study, which achieved its primary endpoint of change from baseline at week 24 in a six-minute walk distance. Merck ( MRK ) said Winrevair, or sotatercept, was also found to improve multiple secondary endpoints during the study.
Merck ( MRK ) said the approval is valid in all 27 member states of the European Union, plus Iceland, Norway, and Liechtenstein.
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