The Food and Drug Administration (FDA) in the US has approved MSD’s (known as Merck in the US and Canada) heart failure treatment Verquvo (vericiguat).
Verquvo has been approved to reduce the risk of cardiovascular death and heart failure hospitalisation, following a hospitalisation 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 is based on the results from the Phase III VICTORIA trial, Verquvo met the primary efficacy objective based on a time-to-event analysis.
Over the duration of the study, investigators observed a 4.2% reduction in annualised absolute risk of cardiovascular death or heart failure hospitalisations compared to placebo.
“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. said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
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,” he added.
According to MSD, the FDA approval of Verquvo makes it the first treatment for chronic heart failure approved specifically for patients following hospitalisation for heart failure or need for outpatient IV diuretics.