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Austedo
Published
Product name
Austedo
Active ingredient
Deutetrabenazine
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
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
How this medicine works
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.
Why the TGA approved or did not approve this medicine
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.
Sponsor