Merck Announces U.S. FDA Approval of VERQUVO® (vericiguat)
KENILWORTH, NJ, USA I January 20, 2021 I Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved VERQUVO, a soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. The approval of VERQUVO by the FDA, which is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics, is based on the results of the pivotal Phase 3 VICTORIA trial and follows a priority regulatory review. VERQUVO (vericiguat) 2.5 mg, 5 mg, and 10 mg tablets is being jointly developed with Bayer AG.
The VERQUVO label contains a boxed warning that indicates that VERQUVO should not be administered to pregnant females because it may cause fetal harm. For more information, see “Selected Safety Information” below.
“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. 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,” said Dr. Paul W. Armstrong, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial. “The approval of VERQUVO provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”
In VICTORIA, the primary efficacy objective was to determine whether VERQUVO is superior to placebo, both in combination with other heart failure therapies, in reducing the risk of cardiovascular death or heart failure hospitalization in adults with symptomatic chronic heart failure and ejection fraction less than 45% following a worsening heart failure event. VERQUVO met the primary efficacy objective based on a time-to-event analysis (hazard ratio [HR]: 0.90, 95% confidence interval [CI], 0.82-0.98; p=0.019). Over the course of the study, there was a 4.2% reduction in annualized absolute risk with VERQUVO compared with placebo. Therefore, 24 patients would need to be treated over an average of one year to prevent one primary endpoint event.
“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. We are pleased to offer a meaningful new treatment option for appropriate patients with symptomatic chronic heart failure,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”
https://pipelinereview.com/
