FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Austedo (deutetrabenazine)

Indications:

Treatment of chorea associated with Huntington disease was approved in April 2017. A second indication for tardive dyskinesia was approved in August 2017.

Mechanism:

Vesicular monoamine transporter-2 (VMAT-2) inhibitor, which decreases uptake of monoamines (eg, dopamine, serotonin, norepinephrine, histamine) into synaptic vesicles and depletes monoamine stores from nerve terminals.

Dosage:

Dose is determined individually for each patient based on reduction of chorea and tolerability.

Initial dose when not being switched from tetrabenazine: 6 mg PO once daily.

May increase dose at weekly intervals in increments of 6 mg/day; not to exceed 48 mg/day.

Administer doses ≥12 mg/day in 2 divided doses.

If switching from tetrabenazine to deutetrabenazine, discontinue tetrabenazine and initiate deutetrabenazine the following day (see prescribing information for recommended dosing).

Approval:

Approval was based on a double-blind multicenter trial conducted in 90 ambulatory patients at 34 centers in the United States and Canada, with 45 patients randomly assigned to deutetrabenazine and 45 to placebo. Deutetrabenazine or placebo was titrated to optimal dose level over 8 weeks and maintained for 4 weeks, followed by a 1-week washout. Baseline total maximal chorea score was 8 or higher in study participants. Results showed improvement in the Unified Huntington Disease Rating Scale total maximal chorea scores for patients taking deutetrabenazine of 4.4 units from baseline to the maintenance period (average of week 9 and week 12), compared with approximately 1.9 units for patients taking placebo. The treatment effect of –2.5 units was statistically significant (P<0.0001).

Reference:

Huntington Study Group. Effect of deutetrabenazine on chorea among patients with Huntington disease: A Randomized Clinical Trial. JAMA. 2016;316(1):40-50.

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