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Austedo
Sponsor
ARTGs
330021, 330022 and 330023
330021, 330022 and 330023
330021, 330022 and 330023
Device/Product name
Austedo
Active Ingredient
Deutetrabenazine
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 Austedo 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 |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 30 March 2020 |
| First round evaluation completed | 1 September 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 2 November 2020 |
| Second round evaluation completed | 29 April 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 2 March 2021 |
| Sponsor's pre-Advisory Committee response | 16 March 2021 |
| Advisory Committee meeting | 8 and 9 April 2021 |
| Registration decision (Outcome) | 26 May 2021 |
| Completion of administrative activities and registration on ARTG | 2 June 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 190 |
*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
Modified release tablet
Strength
6 mg, 9 mg and 12 mg
Other ingredients
Butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene oxide, polysorbate 80, povidone, and the printing ink, opacode monogramming ink S-1-17823 black. The 6 mg tablets also contain opadry II complete film coating system 85F100011 purple. The 9 mg tablets also contain opadry II complete film coating system 85F90637 blue. The 12 mg tablets also contain opadry II complete film coating system 85F170047 beige.
Containers
Bottle
Pack sizes
60
Routes of administration
Oral
Dosage
The dose of Austedo is determined individually for each patient based on reduction of chorea or tardive dyskinesia and tolerability. When first prescribed to patients who are not being switched from tetrabenazine (a related vesicular monoamine transporter type 2 (VMAT2) inhibitor), the recommended starting dose of Austedo is 6 mg administered orally once daily for patients with Huntington’s disease and 12 mg per day (6 mg twice daily) for patients with tardive dyskinesia.
For further information refer to the Product Information.
Pregnancy category
Category B3Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.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
Austedo (deutetrabenazine) was approved for the following therapeutic use:
Austedo is indicated for the treatment of:
- chorea associated with Huntington's disease
- tardive dyskinesia in adults
What is this medicine and how does it work
Deutetrabenazine is the deuterated form of tetrabenazine. The precise mechanism by which deutetrabenazine and tetrabenazine exert their effects in the treatment of tardive dyskinesia and chorea in patients with Huntington's disease is unknown but is believed to be related to the reversible depletion of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (α-dihydrotetrabenazine (HTBZ) and β-HTBZ) of deutetrabenazine, are reversible inhibitors of vesicular monoamine transporter 2 (VMAT2), resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.
What post-market commitments will the sponsor undertake
- Austedo (deutetrabenazine) is to be included in the Black Triangle Scheme. The Product Information and Consumer Medicines Information for Austedo 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 deutetrabenazine risk management plan (RMP) (version 1.1, dated 23 October 2020, data lock point 15 September 2020), included with submission PM-2020-00739-1-1, 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 the 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 the 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 European Union (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 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. Each report must have been prepared within ninety calendar days of the data lock point for that report.