The approval come following the results of a phase 3 trial.
The U.S. Food and Drug Administration (FDA) has approved VERQUVO to reduce the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure and ejection fraction less than 45%.
The FDA approval comes following the results of the phase 3 VICTORIA trial of more than 5,000 adults. The goal of the VICTORIA trial was to determine whether VERQUVO was superior to placebo 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.
Participants received up to the target maintenance dose of VERQUVO 10 mg once daily or matching placebo. The therapy started at 2.5 mg once daily and was increased in two-week intervals to 5 mg once daily and then 10 mg once daily. Placebo doses were adjusted the same way.
Investigators found the drug met the primary efficacy objective (HR, .9; 95% CI, .82-.98; P = .019). Overall, there was a 4.2% reduction in annualized absolute risk with VERQUVO compared to placebo.
“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,” Paul W. Armstrong, M.D., cardiologist and university professor of medicine at the Canadian VIGOUR Centre, University of Alberta, and study chair of the VICTORIA trial, said. “The approval of VERQUVO provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”
The box label indicates VERQUVO should not be used by pregnant females as it may cause fetal harm.