Merck's Winrevair gets expanded indication in US

Published: 2025-10-27 09:23:16 ET MRK

Published on 10/27/2025 at 09:23 am EDT

Merck has announced that the US FDA has approved an update to the label for Winrevair, an activin signaling inhibitor, based on the Phase 3 ZENITH trial in the treatment of pulmonary arterial hypertension (PAH).It is now approved in the US to improve exercise capacity and WHO functional class, and reduce the risk of clinical worsening, including hospitalization for PAH, lung transplantation and ultimately death.In the ZENITH study, the combination of Winrevair with background therapy reduced the risk of major morbidity and mortality in adults with WHO functional class III or IV PAH by 76% compared to placebo.The ZENITH data add to a growing body of evidence supporting a positive benefit profile for Winrevair in a broad range of adult patients with PAH, the pharmaceutical company said.