Chronic heart failure in adult patients with reduced ejection fraction : Verquvo approved in the European Union
The European Commission ( EC ) has granted marketing authorization in the European Union ( EU ) for soluble guanylate cyclase ( sGC ) stimulator Verquvo ( Vericiguat ).
In the EU, Verquvo ( 2.5 mg, 5 mg, and 10 mg ) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous ( IV ) therapy.
In January of 2021, the U.S. Food and Drug Administration ( FDA ) approved Verquvo in the U.S. to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.
In the U.S., the product label for Verquvo contains a boxed warning that indicates that Verquvo should not be administered to pregnant females because it may cause fetal harm.
Verquvo is a stimulator of soluble guanylate cyclase, 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.
Verquvo is contraindicated in patients with concomitant use of other soluble guanylate cyclase stimulators.
Concomitant use of Verquvo with PDE-5 inhibitors is not recommended because of the potential for hypotension.
In a clinical trial, the most commonly observed adverse events with Verquvo vs placebo, occurring at a frequency greater than or equal to 5%, were hypotension ( 16% vs 15% ) and anemia ( 10% vs 7% ). ( Xagena )
Source: Merck & Bayer, 2021