28.06.2024 14:43:58 - dpa-AFX: Merck: CHMP Recommends Approval Of WINREVAIR In Pulmonary Arterial Hypertension
KENILWORTH (NJ) (dpa-AFX) - 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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