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Trientine Waymade
Sponsor
Device/Product name
Trientine Waymade
Active Ingredient
Trientine dihydrochloride
Date of decision
Published
Submission type
New chemical entity
ATC codes
Not yet assigned
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 Trientine Waymade 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.
| Description | Date |
|---|---|
| Designation (Orphan) | 7 August 2019 |
| Submission dossier accepted and first round evaluation commenced | 30 January 2020 |
| First round evaluation completed | 30 June 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 31 August 2020 |
| Second round evaluation completed | 19 October 2020 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 2 November 2020 |
| Sponsor's pre-Advisory Committee response | 13 November 2020 |
| Advisory Committee meeting | 3 to 4 December 2020 |
| Registration decision (Outcome) | 7 January 2021 |
| Completion of administrative activities and registration on ARTG | 11 January 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 188 |
*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
Capsule
Strength
250 mg
Other ingredients
Stearic acid, gelatin, titanium dioxide, sunset yellow for colouring food (FCF), purified water, TekPrint SW-9008 Black Ink
Containers
Bottle
Pack sizes
100 capsules
Routes of administration
Oral
Dosage
The starting dose would usually correspond to the lowest recommended dose and the dose should subsequently be adapted according to the patient’s clinical response (see section 4.4 special warnings and precautions for use in the product information (PI)).
The daily dose of Trientine Waymade should be increased only when the clinical response is not adequate, or the concentration of free serum copper is persistently above 3.1 µmol/L. Optimal long term maintenance dosage should be determined at 6 to 12 month intervals.
Adults
The recommended initial dose of Trientine Waymade is 750 to1250 mg/day (equivalent to 500 to 833 mg/day trientine base) for adults given in divided doses two, three or four times daily. This may be increased to a maximum of 2000 mg/day (1333 mg/day trientine base) for adults.
Paediatric patients
The recommended initial dose of Trientine Waymade is 20 mg/kg/day (equivalent to 13 mg/kg/day trientine base) rounded off to the nearest 250 mg, given in two or three divided doses. This may be increased to a maximum of 1500 mg/day (equivalent to 1000 mg/day trientine base) for paediatric patients age 12 or under.
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
Trientine Waymade (trientine dihydrochloride) was approved for the following therapeutic use:
Trientine Waymade is indicated in the treatment of patients with Wilson's disease who areintolerant of penicillamine.
What is this medicine and how does it work
Trientine has a structure similar to polyamines and chelates copper by forming a stable complex with the four constituent nitrogens in a planar ring. The pharmacodynamic action of trientine is dependent on its property of chelating copper and elimination of the trientine copper complex in the urine. Trientine may also chelate copper in the intestinal tract and in the process inhibit copper absorption.
What post-market commitments will the sponsor undertake
- Trientine Waymade (trientine dihydrochloride) is to be included in the Black Triangle Scheme. The PI and Consumer Medicines Information (CMI) for Trientine Waymade 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 trientine dihydrochloride Australian Risk Management Plan (RMP) (version 0.3, data lock point 11 December 2019) included with submission PM-2019-05976-1-3, 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).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of this approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of this approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of this 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. Each report must have been prepared within ninety calendar days of the data lock point for that report.