The U.S. Food and Drug Administration (FDA) approved Merck and Bayer’s heart failure drug vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator.
Vericiguat will be marketed under the brand name Verquvo and is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics. Specifically, it was approved to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.
Verquvo, which was jointly developed with Bayer, was approved under priority review based on results from the Phase III VICTORIA study. The VICTORIA study met the primary endpoint by demonstrating a statistically significant reduction of the first occurrence of a composite of cardiovascular death or heart failure hospitalization. The trial was assessing the efficacy of the medication in those patients’ chronic heart patients with reduced ejection fraction (HFrEF). Vericiguat was being tested in combination with available heart failure therapies against placebo. Over the course of the study, there was a 4.2% reduction in annualized absolute risk with Verquvo compared with placebo. Therefore, 24 patients would need to be treated over an average of one year to prevent one primary endpoint event, the companies said in a joint statement.
Roy Baynes, head of global clinical development and chief medical officer at Merck Research Laboratories, said clinical studies have shown Verquvo is able to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics.