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Verquvo

Published
Product name
Verquvo
Active ingredient
Vericiguat
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for

Verquvo (vericiguat) was approved for the following therapeutic use:

Verquvo is indicated in addition to standard of care therapy for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45% who are stabilised after a recent heart failure decompensation event requiring admission and/or IV diuretic therapy (see Section 5.1 Pharmacodynamic properties - Clinical trials).

How this medicine works

Vericiguat is a stimulator of soluble guanylate cyclase (sGC). Heart failure is associated with impaired synthesis of nitric oxide (NO) and decreased activity of its receptor, sGC. Soluble guanylate cyclase catalyses synthesis of intracellular cyclic guanosine monophosphate (cGMP), an important signalling molecule that regulates critical physiological processes such as cardiac contractility, vascular tone, and cardiac remodelling. Deficiency in sGC-derived cGMP contributes to myocardial and vascular dysfunction. Vericiguat restores the relative deficiency in this signalling pathway by directly stimulating sGC, independently of and synergistically with NO, to augment the levels of intracellular cGMP, which may improve both myocardial and vascular function. The complementary cardiovascular benefits of vericiguat in heart failure patients are therefore attributed to the active restoration of the deficient NO-sGC-cGMP pathway driving heart failure progression.

Why the TGA approved or did not approve this medicine

The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Verquvo was considered favourable for the therapeutic use approved.