BAY 1021189 filed with FDA for heart failure.- Merck Inc

Merck Inc., announced that the FDA has accepted for priority review the New Drug Application (NDA) for BAY 1021189 (vericiguat), an orally administered soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a worsening heart failure event in patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), in combination with other heart failure therapies. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of January. 20, 2021. Vericiguat is being jointly developed with Bayer AG. The application is based on results from the Phase III VICTORIA trial, which is the first contemporary outcomes study focused exclusively on a population with worsening chronic heart failure who are at high risk for cardiovascular mortality and repeated heart failure hospitalizations. Data from VICTORIA were presented at the virtual American College of Cardiology’s 69th Annual Scientific Session together with World Congress of Cardiology (ACC.20/WCC) and published in The New England Journal of Medicine. /p>The application is based on results from the Phase III VICTORIA trial, which is the first contemporary outcomes study focused exclusively on a population with worsening chronic heart failure who are at high risk for cardiovascular mortality and repeated heart failure hospitalizations. Data from VICTORIA were presented at the virtual American College of Cardiology’s 69th Annual Scientific Session together with World Congress of Cardiology (ACC.20/WCC) and published in The New England Journal of Medicine. See-"Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction"- Paul W. Armstrong, M.D., Burkert Pieske, M.D., Kevin J. Anstrom, Ph.D., Justin Ezekowitz, M.B., B.Ch., Adrian F. Hernandez, M.D., M.H.S., , et al., for the VICTORIA Study Group*-May 14, 2020N Engl J Med 2020; 382:1883-1893. . DOI: 10.1056/NEJMoa1915928..