Merck & Co Inc. (MRK) announced on Monday that it has received approval from the European Commission for Winrevair, in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adults classified under World Health Organization Functional Class II to III. This authorization aims to enhance exercise capacity in patients.
The approval was grounded on the findings of the Phase 3 STELLAR trial, which involved adults with PAH. The study compared the efficacy of Winrevair to a placebo, focusing on the primary endpoint of change from baseline in the six-minute walk distance at Week 24. Results demonstrated a statistically significant and clinically meaningful improvement with Winrevair, showing an average increase of 40.8 meters in the six-minute walk distance over the placebo.
Winrevair is already approved in the United States for the treatment of adults with PAH.
