FDA Approves Merck’s Symptomatic Heart Failure Drug

Merck, known as MSD outside the United States and Canada, announced on Jan. 20, 2021 that FDA has approved Verquvo, its soluble guanylate cyclase stimulator for the reduction of the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure.

The approval was based on positive data from a randomized, parallel-group, placebo-controlled, double-blind, event-driven, multi-center trial that compared the drug to a placebo in more than 5000 participants with symptomatic chronic heart failure, Merck said in a company press release. Verquvo proved to be more effective than the placebo in reducing the risk of cardiovascular death or heart failure hospitalization based on a time-to-event analysis.

“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 [intravenous] 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, in the press release. “This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”