The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for vericiguat (Merck) to reduce the risk of cardiovascular death and heart failure hospitalization following a worsening heart failure event in patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), in combination with other heart failure therapies.
The application is supported by data from the multicenter, double-blind, placebo-controlled phase 3 VICTORIA trial that evaluated the efficacy and safety of vericiguat, a soluble guanylate cyclase stimulator, in 5050 adult patients with HFrEF following a decompensation event (defined as heart failure hospitalization or receiving an intravenous diuretic for heart failure without hospitalization). Patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of <45% were included in the trial.
Patients were randomized to receive vericiguat 10mg once daily (n=2526) or placebo (n=2524) in combination with other heart failure therapies. The primary end point was the composite of time to first occurrence of heart failure hospitalization or cardiovascular death.
Results from the study showed that 35.5% of patients who received vericiguat experienced a primary-outcome event compared with 38.5% of placebo patients (hazard ratio [HR], 0.90; 95% CI, 0.82-0.98; P =.02) over a median of 10.8 months. Additionally, treatment with vericiguat reduced the incidence of heart failure hospitalizations (27.4% vs 29.6% for placebo; HR 0.90; 95% CI, 0.81-1.00) and death from cardiovascular causes (16.4% vs 17.5% for placebo; HR 0.93; 95% CI, 0.81-1.06).
Regarding safety, the rate of serious adverse events was found to be similar between vericiguat and placebo (32.8% vs 34.8%, respectively). However, the vericiguat treatment arm experienced higher rates of symptomatic hypotension (9.1% vs 7.9%, respectively; P =.12) and syncope (4.0% vs 3.5%, respectively; P =.30) compared with placebo.
A Prescription Drug User Fee Act (PDUFA) target date of January 20, 2021 has been set for this application.
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