Merck: CHMP Recommends Approval Of WINREVAIR In Pulmonary Arterial Hypertension - Quick Facts

(RTTNews) - Merck (MRK) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the approval of WINREVAIR, in combination with other pulmonary arterial hypertension therapies, for the treatment of PAH in adult patients with World Health Organization Functional Class II to III, to improve exercise capacity. The European Commission decision on the marketing authorization application is expected in the third quarter of 2024.

WINREVAIR was previously granted Priority Medicines and orphan designation by the EMA for the treatment of pulmonary arterial hypertension. In March 2024, WINREVAIR was approved by the FDA.

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