07:22 AM EDT, 06/28/2024 (MT Newswires) -- Merck ( MRK ) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the approval of Winrevair in combination with other therapies to treat pulmonary arterial hypertension in adult patients.

The European Commission will review the health agency's recommendation and decide on the marketing authorization application by Q3.

The recommendation was based on data from a phase 3 study that showed a statistically significant and clinically meaningful improvement in six-minute walk distance and multiple secondary outcome measures in patients treated with Winrevair.

In March, Winrevair was approved by the US Food and Drug Administration.

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