December 12, 2025 — Leads & Copy —
Merck (NYSE: MRK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approving an expanded indication for WINREVAIR™ to treat pulmonary arterial hypertension (PAH) in adult patients with WHO Functional Class (FC) II, III, and IV, based on the Phase 3 ZENITH study. A final decision is expected in the first quarter of 2026.
The CHMP recommendation is based on data from the Phase 3 ZENITH trial, which showed WINREVAIR with background therapy reduced the risk of major morbidity and mortality outcomes by 76% in adults with PAH WHO functional class III or IV, compared to placebo.
WINREVAIR is the first activin signaling inhibitor therapy for PAH approved in all 27 member states of the EU, as well as Iceland, Liechtenstein and Norway, and is currently approved in more than 50 countries.
Dr. Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories, commented on the extended use of WINREVAIR to include WHO FC II, III and now IV patients, with the goal of treatment beyond improving exercise capacity.
Source: Merck
