Merck has gained FDA approval for vericiguat, the company’s soluble guanylate cyclase (sGC) stimulator, as a treatment option for patients showing signs of chronic heart failure.
Sold as Verquvo, the medication was designed to reduce a patient’s risk of cardiovascular death or heart failure hospitalization following hospitalization or outpatient IV diuretic therapy if they present with symptomatic chronic heart failure and ejection fraction less than 45%.
The FDA’s decision was based largely on the results of the VICTORIA trial, which found that vericiguat was able to successfully reduce a patient’s absolute risk of cardiovascular death or heart failure hospitalization compared to a placebo.
“Verquvo has been shown to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics,” Roy Baynes, MD, PhD, senior vice president of global clinical development and chief medical officer of Merck Research Laboratories, said in a statement. “We are pleased to offer a meaningful new treatment option for appropriate patients with symptomatic chronic heart failure. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”
“Patients with symptomatic chronic heart failure and reduced ejection fraction have a high risk for hospitalization after experiencing symptoms of heart failure requiring outpatient IV diuretic treatment or hospitalization,” added Paul W. Armstrong, MD, a cardiologist at the University of Alberta and study chair of the VICTORIA trial. “By some estimates, more than half of these patients are rehospitalized within a month of discharge due to a worsening event and approximately one in five die within two years. The approval of Verquvo provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”
This medication should not be taken by pregnant women, Merck emphasized in its statement.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.