Merck 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. WINREVAIR was previously granted Priority Medicines and orphan designation by the EMA for the treatment of PAH. The European Commission will now review the CHMP recommendation, and the EC’s decision on the marketing authorization application of WINREVAIR in the EU, Iceland, Liechtenstein and Norway is expected in the third quarter of 2024.
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