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FDA approved vericiguat (Verquvo) on Wednesday to lower cardiovascular events in patients with heart failure with reduced ejection fraction (HFrEF) who had recently been hospitalized or had received IV diuretic therapy, .

The soluble guanylate cyclase (sGC) stimulator was cleared as a therapy that reduces the risk of cardiovascular death and heart failure hospitalization in these patients. This makes it the first chronic heart failure treatment approved specifically for the recently decompensated population.

Regulatory approval was based on the VICTORIA trial, first presented at the 2020 virtual American College of Cardiology annual meeting, which had 5,050 recently decompensated HFrEF patients randomized to vericiguat (up to 10 mg once daily) or placebo.

In the study, vericiguat reduced the incidence of combined cardiovascular death or hospitalization for heart failure over a median 11 months of follow-up (35.5% vs 38.5%, P=0.02). In particular, the benefit of the sGC stimulator was driven by the drop in heart failure hospitalizations, investigators reported.

Recently decompensated individuals tend to have more severe disease and fewer therapeutic options compared with other heart failure patients.

"By some estimates, more than half of these patients are rehospitalized within a month of discharge due to a worsening event and approximately one in five die within two years," VICTORIA study chair Paul Armstrong, MD, of University of Alberta, Edmonton, said in a statement.

Vericiguat's label includes a boxed warning that it should not be taken by pregnant women due to potential fetal toxicity.

The benefit of the sGC stimulator remains confined to the realm of HFrEF: recently, Armstrong's group reported that vericiguat failed to improve physical function in heart failure with preserved ejection fraction in the VITALITY-HFpEF trial.

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