The U.S. Food and Drug Administration ( FDA ) has approved soluble guanylate cyclase ( sGC ) stimulator Vericiguat under the brand name Verquvo.
Vericiguat 2.5 mg, 5 mg, and 10 mg is indicated to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous ( IV ) diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.
The approval is based on the results of the pivotal phase III VICTORIA trial, published in the New England Journal of Medicine ( NEJM ).
VICTORIA trial was the first positive contemporary outcomes study focused exclusively on a chronic heart failure patient population following a hospitalization for heart failure or need for outpatient intravenous diuretics.
Results have shown that Vericiguat in combination with available heart failure therapies provided an absolute risk reduction of 4.2 per 100 patient years for the primary endpoint, which was a composite of time to first event of cardiovascular death or hospitalization for heart failure.
The Number Needed to Treat ( NNT ) is 24.
Vericiguat ( 2.5 mg, 5 mg, and 10 mg ) is an oral once daily stimulator of soluble guanylate cyclase ( sGC ), an important enzyme in the nitric oxide ( NO ) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate ( cGMP ), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling.
Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, Vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation. ( Xagena )
Source: Bayer, 2021