16 July 2020 - Application based on first contemporary outcomes study focused exclusively on chronic heart failure patient population following a worsening event.
Merck announced today that the U.S. FDA has accepted for priority review the new drug application for vericiguat, an orally administered soluble guanylate cyclase stimulator, to reduce the risk of cardiovascular death and heart failure hospitalisation following a worsening heart failure event in patients with symptomatic chronic heart failure with reduced ejection fraction, in combination with other heart failure therapies.
The FDA has set a Prescription Drug User Fee Act, or target action date, of 20 January 2021. Vericiguat is being jointly developed with Bayer.