FDA Approves VERQUVO For Patients With Chronic Heart Failure

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.