"FDA Greenlights Merck's WINREVAIR™ for Rare, Deadly Lung Condition"

The FDA has approved Merck's WINREVAIR (sotatercept-csrk) for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events. WINREVAIR, a first-in-class activin signaling inhibitor therapy, demonstrated significant clinical benefits in a Phase 3 trial, including improved exercise capacity and reduced risk of death or PAH clinical worsening events. Healthcare providers should monitor hemoglobin and platelets before each dose, as WINREVAIR may increase hemoglobin and decrease platelet count. The medication is expected to be available in the U.S. by the end of April and comes with support for patients through the Merck Access Program.