VERQUVO® (vericiguat) is a stimulator of soluble guanylate cyclase (sGC) indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalisation.
It is the first treatment for chronic HF that is specifically approved for adult patients who are hospitalised for HF or has symptomatic chronic HF and ejection fraction less than 45%, requiring outpatient intravenous (IV) diuretics.
Co-developed by Bayer and Merck, VERQUVO is available as round, biconvex, film-coated tablets in 2.5mg (white-coloured), 5mg (brown-red coloured), and 10mg (yellow-orange coloured) dosage strengths.
The new drug application (NDA) for vericiguat was submitted to the US Food and Drug Administration (FDA) in May 2020, which was accepted for priority review in July 2020.
The companies submitted the marketing authorisation application (MAA) for vericiguat to European Union (EU) and Japan in June 2020 and China in August 2020. The MAA for the drug has also been submitted to multiple other countries globally.
The FDA approved VERQUVO for the treatment of heart failure with reduced ejection fraction (HfrEF), in January 2021.
HFrEF, previously known as systolic heart failure, is characterised by the inability of the heart (particularly the left ventricle) to properly eject sufficient blood during the contraction phase.
Approximately 6.2 million patients in the US suffer from HF, of which approximately 40% to 50% of patients have HFrEF.
Around 30% of symptomatic chronic HF patients report worsening of the condition, which is characterised by progressive signs or a recent HF case.
Approximately 50% of the patients with deteriorating chronic HFrEF are re-hospitalised within 30 days of deterioration, and an estimated one in five patients with deteriorating chronic HFrEF dies within two years.
The typical symptoms of HFrEF include weakness, oedema, orthopnoea, dyspnoea, and paroxysmal nocturnal dyspnoea.
Vericiguat is an oral, once-daily sGC stimulator, an essential enzyme in the nitric oxide (NO) signalling pathway.
When NO binds to sGC, the enzyme speeds up the production of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the management of vascular tone, cardiac contractility, and cardiac remodelling.HF is associated with impaired NO synthesis and decreased sGC activity, which can lead to myocardial and vascular dysfunction.
By explicitly activating sGC, independently and synergistically with NO, vericiguat increases intracellular cGMP levels, causing smooth muscle relaxation and vasodilation.
The FDA’s approval of VERQUVO is based on the results of a randomised, double-blind, parallel-group, placebo-controlled, event-driven, multi-centre, pivotal phase three VICTORIA clinical trial.
A total of 5,050 adult patients with symptomatic chronic HF were randomised to receive either VERCUVO 10mg or corresponding placebo.
The treatment began with the dosage strength of 2.5mg once daily which was increased to 5mg in approximately two-week intervals and then up to 10mg target dose, as tolerated. The doses of placebo were adjusted similarly.
Approximately one year later, 90% of patients in both the VERQUVO and placebo arms were treated with the 10mg target maintenance dose.
The primary goal of the study was to measure the time to the first cardiovascular death event or HF hospitalisation case. The median follow-up period was 11 months for the primary outcome.
The mean left ventricular ejection fraction (LVEF) of the patients who participated in the study was 29%. About half of all patients had an EF of less than 30% and 14% of the group had an EF of between 40 and 45%.
At randomisation, the median NT-pro B-type natriuretic peptide (NT-proBNP) level was 2800 pg / ml.
In the clinical trial, VERQUVO was better than the placebo in reducing the risk of cardiovascular death or HF, based on a time-to-event evaluation.
A 4.2% reduction was observed in the annualised absolute risk (ARR) with VERQUVO compared to placebo during the study. The treatment result represented a decline in both cardiovascular death and HF.
The most common adverse reactions observed in the patients during the clinical trial were anaemia and hypotension.
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