Verquvo
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
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.
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).
- 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.