The FDA has granted priority review for a New Drug Application (NDA) for vericiguat as a treatment for heart failure with reduced ejection fraction, according to a press release from the manufacturer. 

If approved, the drug would “reduce the risk of cardiovascular death and heart failure hospitalization following worsening heart failure events” in patients with that specific form of heart failure, along with other treatments. The application was filed following the completion of the phase III VICTORIA trial. The trial’s results were presented at the virtual ASCO meeting this year and published in the New England Journal of Medicine.

The VICTORIA trial compared vericiguat to placebo in combination with other heart failure therapies in patients with worsening chronic heart failure, reduced left ventricular ejection fraction of <45% within a year of being randomized after a decompensation event. According to the release, the primary endpoint was the composite of time to the first occurrence of hospitalization for heart failure or cardiovascular death. Secondary endpoints included time to cardiovascular death, time to the first occurrence of heart failure hospitalization, and time to all-cause mortality. 

There were more than 5,000 patients enrolled in the trial. Over an average of 10.8 months, a primary-outcome event was reported in 35.5% of the patients in the vericiguat group, compared to 38.5% in the placebo group (hazard ratio, 0.90; 95% CI, 0.82-0.98; P=0.02). In the vericiguat group, 27.4% were hospitalized for heart failure, compared to 29.6% in the placebo group (hazard ratio, 0.90; 95% CI, 0.81-1.00). Composite of death for any cause or heart failure hospitalization was reported in 37.9% in the vericiguat group, compared to 40.9% in the placebo group. 

“For this group of chronic heart failure patients at high risk for future events, vericiguat has the potential to provide a significant addition to usual guideline-based treatment,” lead author Paul W. Armstrong, MD, of the Canadian VIGOUR Centre said in an earlier story on the trial. “We are pleased with the observed absolute risk reduction and are hopeful that this result may open up a new avenue for appropriate patients and a possible path for future discovery in cardiovascular heart disease.”

The FDA has set a target action date of Jan. 20, 2021, for the NDA.