Merck Receives Positive EU CHMP Opinion for WINREVAIR™ (sotatercept) in Pulmonary Arterial Hypertension (PAH)
Merck & Company, Inc. (new) (MRK)
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Source: Business Wire
If approved by the European Commission, WINREVAIR will be the first activin signaling inhibitor therapy for PAH in Europe, offering a new treatment option for certain adults with this rare, progressive diseaseMilestone highlights Merck’s focus on global filings to expand access to WINREVAIR and commitment to patients living with PAH RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, to improve exercise capacity. WINREVAIR was previously granted Priority Medicines (PRIME) and orphan designation by the EMA for the treatment of PAH. The European Commission (EC) will now review th
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