Cuprior
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Designation Orphan | 3 July 2019 |
| Orphan extension | 11 December 2019 |
| Submission dossier accepted and first round evaluation commenced | 30 June 2020 |
| First round evaluation completed | 1 December 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 1 February 2021 |
| Second round evaluation completed | 16 March 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 3 May 2021 |
| Sponsor's pre-Advisory Committee response | 18 May 2021 |
| Advisory Committee meeting | 3 and 4 June 2021 |
| Registration decision (Outcome) | 15 July 2021 |
| Completion of administrative activities and registration on ARTG | 28 September 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 212 |
*Statutory timeframe for standard applications is 255 working days
Mannitol, colloidal anhydrous silica, glycerol dibehenate, polyvinyl alcohol, purified talc, titanium dioxide, polyglycerol esters of fatty acids, iron oxide yellow and sodium lauryl sulfate.
Treatment should only be initiated by specialist physicians with experience in the management of Wilson's disease.
The starting dose would usually correspond to the lowest dose in the range and the dose should subsequently be adapted according to the patient’s clinical response (see Section 4.4 Special warnings and precautions for use of the Product Information).
The recommended dose is between 450 mg and 975 mg (3 to 6½ film coated tablets) per day in 2 to 4 divided doses.
Adult
Dosage depends on the patient's clinical response (see Section 4.2, Dose and method of administration in Product Information)
Paediatric population
Dosage depends on age and body weight (see Section 4.2, Dose and method of administration in Product Information).
For further information refer to the Product Information.
Cuprior (trientine tetrahydrochloride) was approved for the following therapeutic use:
Cuprior is indicated for the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.
- Cuprior (trientine tetrahydrochloride) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicine Information (CMI) for Cuprior 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 Cuprior European Union (EU)-risk management plan (RMP) (version 1.5, dated April 2017, data lock point 31 October 2015), with Australian specific annex (version 0.1, dated January 2020), included with submission PM-2020-02473-1-3, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of RMP 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.