Heart failure is a serious matter and January of 2021 could bring some very important news to the 6.5 million Americans who have heart failure. It has been estimated that 40% to 50% of those patients also have heart failure with reduced ejection fraction (HFrEF). This smaller subset of patients with systolic heart failure are at a higher risk of death and other adverse events.
The U.S. Food and Drug Administration (FDA) has its Prescription Drug User Fee Act (PDUFA) for a drug called Vericiguat specifically targeting HFrEF set for January 20, 2021. Vericiguat is being jointly developed by Merck & Co. and Bayer AG.
Vericiguat is an orally administered soluble guanylate cyclase stimulator targeting HFrEF in combination with other heart failure therapies. The FDA’s review of this drug application is being evaluated on results from the Phase 3 VICTORIA trial. This was said to be the first contemporary outcomes study which was focused exclusively on patients with worsening chronic heart failure who are also at high risk for cardiovascular mortality and repeated heart failure hospitalizations.
According to a previous corporate press release at the time the FDA set the action date, Merck and Bayer noted that approximately 30% of patients with symptomatic chronic heart failure will experience worsening of the disease. An alarming figure also noted that approximately half of patients with worsening chronic HFrEF have to back into the hospital within 30 days of a worsening event. And for the ultimate figure showing just how serious HFrEF is, Merck and Bayer have estimated that one-fifth of patients with worsening chronic HFrEF will die within two years.
Data from the VICTORIA study was previously presented at the virtual American College of Cardiology’s 69th Annual Scientific Session together with World Congress of Cardiology. The results were published in The New England Journal of Medicine in May of 2020. According to the NEJM’s assessment, the incidence of death from cardiovascular causes and hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo.
The Phase 3 study was a randomized, placebo-controlled, parallel-group, multi-center and double-blind. It was evaluated against placebo in combination with available heart failure therapies in patients with worsening chronic heart failure. With a study population of 5,050 patients, the primary endpoint was the composite of time to first occurrence of heart failure hospitalization or cardiovascular death. Merck and Bayer had also noted that secondary endpoints included time to occurrence of cardiovascular death, time to first occurrence of heart failure hospitalization, time to total heart failure hospitalizations, time to the composite of all-cause mortality or heart failure hospitalization, and time to all-cause mortality.
The VICTORIA study was also conducted under scientific oversight of the Canadian VIGOUR Centre and the Duke Clinical Research Institute. Merck executed the study spread over more than 600 centers in more than 40 countries which included the United States, Europe, Japan and China.
A visualization of VICTORIA’s cumulative incidence of the primary and secondary outcomes has also been provided for further evaluation.