Merck's Winrevair Gets Approval In Pulmonary Arterial Hypertension In Europe

(RTTNews) - Merck & Co Inc. (MRK), Monday said it received approval from the European Commission for Winrevair in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adults with World Health Organization Functional Class II to III, to improve exercise capacity.

The approval was based on results from the Phase 3 STELLAR trial in adults with PAH, which compared Winrevair to placebo. The primary efficacy endpoint of the study was change from baseline at Week 24 in six-minute walk distance. Treatment with Winrevair resulted in a statistically significant and clinically meaningful improvement in six-minute walk distance of 40.8 meters over placebo.

Winrevair is already approved in the U.S. for the treatment of adults with PAH.