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Austedo

9 June 2021

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summary

Summary of submission

Submission type
New chemical entity
Product name
Austedo
Active ingredients
Deutetrabenazine
ATC codes
Not yet assigned
Decision
Approved
Date of decision
26 May 2021
Date of entry onto ARTG
2 June 2021
Original publication date
9 June 2021
ARTG numbers
330021, 330022 and 330023
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.
Sponsor
Teva Pharma Australia Pty Ltd
Sponsor address
Level 1, 37 Epping Road, Macquarie Park NSW 2113
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 B3

Drugs 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?

What was the decision based on?

What steps were involved in the decision process?

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.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.