Merck claimed that its Verquvo is the first soluble guanylate cyclase stimulator to receive FDA approval for the treatment of heart failure
Merck office in Upper Gwynedd Township, Montgomery County. (Credit: Montgomery County Planning Commission/Wikipedia.)
Merck has secured the US Food and Drug Administration (FDA) approval for its Verquvo to treat a type of heart failure (HF).
FDA indicated Verquvo for reducing the risk of cardiovascular death and HF hospitalisation, in adults who were previously hospitalised for HF or needed outpatient intravenous (IV) diuretics, with symptomatic chronic heart failure and ejection fraction less than 45%.
Vericiguat is designed to stimulate soluble guanylate cyclase (sGC), an enzyme that plays important role in the nitric oxide (NO) signalling pathway, for the regulation of vascular tone, cardiac contractility, and cardiac remodelling.
Merck is jointly developing Verquvo in 2.5mg, 5mg, and 10mg tablets formulation under the partnership with German pharmaceutical firm Bayer.
Merck Research Laboratories senior vice president and global clinical development head Roy Baynes said: “Verquvo has been shown to reduce the risk of cardiovascular death and heart failure hospitalisation following a hospitalisation 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. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”
The FDA approval of Verquvo is based on results from VICTORIA, a Phase 3 randomised, parallel-group, placebo-controlled, double-blind, event-driven, multi-centre clinical trial in 5,050 adult patients with symptomatic chronic heart failure.
In the Phase 3 VICTORIA trial, Verquvo met the primary efficacy objective of superiority, both in combination with other heart failure therapies, in reducing the risk of cardiovascular death or heart failure hospitalisation, compared to placebo.
During the study period, the treatment using Verquvo reduced the annualised absolute risk by 4.2% compared with placebo.
The company noted that Verquvo is offered with a label containing boxed warning indicating the drug is not advised for administration to pregnant women as it may cause foetal harm.
VICTORIA trial study chair Paul Armstrong said: “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 rehospitalised 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.”