“WINREVAIR is currently being reviewed by the European Medicines Agency with a decision anticipated in the second half of this year.”

In context

“a steady cadence of clinical regulatory milestones across our pipeline. Today, I will provide updates from our cardiometabolic disease portfolio, HIV and vaccine programs and close with advances in our oncology pipeline. As Rob and Caroline noted, late last month, we received approval from the FDA for WINREVAIR, our first-in-class active and signaling inhibitor for the treatment of dose living with pulmonary arterial hypertension to increase exercise capacity, improve WHO functional class and reduce the risk of clinical worsening events. WINREVAIR is a novel therapeutic option that targets a new PAH treatment pathway and is indicated to treat a broad PAH population. This approval marks a significant step towards our goal of transforming the treatment journey for many patients with PAH. WINREVAIR is currently being reviewed by the European Medicines Agency with a decision anticipated in the second half of this year. The Phase III ZENITH and Hyperion studies evaluating patients with more advanced disease and those earlier on in their disease journey, respectively, are ongoing as well as the Phase II cadence trial evaluating WHO Group II pulmonary hypertension, a type of left heart disease. Our commitment extends to a broad range of pulmonary hypertension, informed by results from the Phase II cohort of the Phase II/III insignia PAH study evaluating MK-5475, our inhaled soluble guanylate cyclase stimulator and the STELLAR trial results for WINREVAIR, we have made the decision to focus the development of MK-5475 on WHO Group 3.1 pulmonary hypertension associated with COPD, and not further proceed in PAH. PH-COPD is an area of significant need with no specific therapies currently approved. Our HIV pipel”