Merck preps filings after blockbuster-in-waiting Winrevair succeeds in severe PAH study

Eight months after snaring an inaugural FDA green light, Merck & Co. is bolstering the case for the chief asset in its $11.5 billion Acceleron acquisition.

In the phase 3 ZENITH study, Merck’s activin signaling inhibitor Winrevair, also known as sotatercept, met its primary endpoint of time to first morbidity or mortality event—which included all-cause death, lung transplantation, or hospitalization for at least 24 hours linked to disease worsening—and helped reduce the risk of morbidity or mortality events versus placebo in adults with pulmonary arterial hypertension (PAH) in functional class III or IV.