FDA Approves Vericiguat (Verquvo) for Treatment of Heart Failure

The US FDA has approved vericiguat (Verquvo) for reducing the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in patients with HFrEF.

The US Food and Drug Administration has approved vericiguat (Verquvo), a soluble guanylate cyclase (sGC) stimulator, for reducing the risk of heart failure, according to a release from Merck.

Based on the results of the pivotal VICTORIA trial, vericiguat (Verquvo) received approval for reducing the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.

“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 Paul W. Armstrong, MD, cardiologist and Distinguished University Professor of Medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial, in the aforementioned release from Merck. “The approval of VERQUVO provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”

Despite historic progress in therapeutics in recent years, heart failure still carries one of the grimmest prognoses of any cardiovascular condition. The first treatment approved specifically for patients following a hospitalization for heart failure or need for intravenous diuretics, vericiguat received approval based on the results of the phase 3 VICTORIA trial, which was originally presented at ACC.20.

VICTORIA was designed as a randomized, parallel-group, placebo-controlled, double-blind, event-driven, multicenter trial and enrolled 5050 patients with New York Heart Association-defined class II, III, or IV chronic heart failure from 600 medical centers in 42 countries. In the trial, which had a primary composite endpoint of death from cardiovascular causes or hospitalization for heart failure, use of vericiguat led to a 10% reductions in the primary endpoint in a time-to-event analysis (HR, 0.90; 95% CI, 0.82-0.98; P=.019).

Additionally, results of the trial indicated vericiguat was associated with a 4.2% reduction in annualized absolute risk compared to placebo, which indicates vericiguat had a number needed to treat of 24 patients.

The release from Merck notes vericiguat 2.5 mg, 5 mg, and 10 mg tablets are being jointly developed with Bayer AG.

“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 Roy Baynes, MD, PhD, 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.”

The release from Merck also notes the vericiguat label also contains a boxed warning. This boxed warning indicates that vericiguat should not be administered to pregnant females because it may cause fetal harm. The release also points out hypotension and anemia were observed adverse events with vericiguat compared to placebo during VICTORIA.

The release from Merck did not mention when the company expects vericiguat to become available to patients within the US.