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Verquvo
Sponsor
ARTGs
339992, 339993, 339994
339992, 339993, 339994
339992, 339993, 339994
Device/Product name
Verquvo
Active Ingredient
Vericiguat
Date of decision
Published
Submission type
New chemical entity
ATC codes
C01DX22
Decision
Approved
What was the decision based on
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.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
This application was evaluated as part of the Australia-Canada-Singapore-Switzerland-United Kingdom (ACCESS) Consortium, with work-sharing between TGA, Health Sciences Authority Singapore and Swissmedic. Each regulator made independent decisions regarding approval (market authorisation) of the new medicine.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 13 August 2020 |
| First round evaluation completed | 14 December 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 11 March 2021 |
| Second round evaluation completed | 6 October 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 31 August 2021 |
| Sponsor's pre-Advisory Committee response | 13 September 2021 |
| Advisory Committee meeting | 30 September and 1 October 2021 |
| Registration decision (Outcome) | 10 November 2021 |
| Completion of administrative activities and registration on ARTG | 15 November 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 199 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Dose forms
Film coated tablet
Strength
2.5 mg, 5 mg, and 10 mg
Other ingredients
Microcrystalline cellulose, croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, hypromellose 5 cP, purified talc, titanium dioxide (E 171), iron oxide red (E 172) (5 mg tablet only), iron oxide yellow (E 172) (10 mg tablet only)
Containers
Blister pack
Pack sizes
14, 28, and 100
Routes of administration
Oral
Dosage
Verquvo should be initiated under the supervision of a cardiologist. The recommended starting dose of Verquvo is 2.5 mg once daily. The dose should be doubled approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient.
Treatment should not be initiated in patients with SBP <100 mmHg (see Section 4.4 Special warnings and precautions for use of the Product Information).
Safety and efficacy of Verquvo have not been established in patients less than 18 years of age (see Section 4.4 Special warnings and precautions for use - Paediatric use and Section 5.2 Pharmacokinetic properties - Special populations of the Product Information).
For further information refer to the Product Information.
Pregnancy category
DDrugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
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).
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
- Verquvo (vericiguat) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Verquvo must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The Verquvo European Union (EU)-risk management plan (RMP) (version 0.4, dated 21 May 2021, data lock point 31 October 2019), with Australian specific annex (version 1.1, dated 28 September 2021), included with Submission PM-2020-03566-1-3, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs). Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter. The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.