Verquvo Approved for Heart Failure with Reduced Ejection Fraction

The approval was based on data from the double-blind, placebo-controlled phase 3 VICTORIA trial.

The Food and Drug Administration (FDA) has approved Verquvo® (vericiguat; Merck) to reduce the risk of cardiovascular (CV) death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic HF and ejection fraction less than 45%. 

The approval was based on data from the 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 symptomatic chronic HF (New York Heart Association class II-IV) and left ventricular ejection fraction (LVEF) less than 45% following a worsening HF event. Patients were randomized to receive vericiguat 10mg once daily (n=2526) or placebo (n=2524) in combination with HF standard of care therapy. 

Results showed that vericiguat was superior to placebo in reducing the risk of CV death or HF hospitalization at a median follow-up of 11 months based on a time-to-event analysis (hazard ratio [HR] 0.90; 95% CI, 0.82-0.98; =.019). Treatment with vericiguat was associated with a 4.2% annualized absolute risk reduction compared with placebo. Additionally, vericiguat reduced the incidence of HF hospitalizations (27.4% vs 29.6% for placebo; HR 0.90; 95% CI, 0.81-1.00) and CV death (16.4% vs 17.5% for placebo; HR 0.93; 95% CI, 0.81-1.06). 

As for safety, the most common adverse reactions (incidence of greater than or equal to 5%) observed with vericiguat were hypotension and anemia. Verquvo is contraindicated in patients with concomitant use of other soluble guanylate cyclase stimulators and in pregnancy due to embryo-fetal toxicity. 

Verquvo will be supplied as 2.5mg, 5mg, and 10mg tablets and is expected to be available in mid-February 2021.

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1.    Merck announces U.S. FDA approval of Verquvo® (vericiguat). [press release]. Kenilworth, NJ: Merck; January 20, 2021. 

2.    Verquvo [package insert]. Whitehouse Station, NJ: Merck & Co., Inc; 2021.