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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Ingrezza (valbenazine)

Indication:

Treatment of tardive dyskinesia in adults.

Mechanism:

The mechanism of action of valbenazine in the treatment of tardive dyskinesia is unknown, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release.

Dosage:

40 mg PO once daily for 1 week, then increase to the recommended dose of 80 mg/day. Continuation of 40 mg once daily may be considered for some patients.

Approval:

Approval was based on the KINECT 3 trial that included patients with schizophrenia, schizoaffective disorder, or a mood disorder who had moderate or severe tardive dyskinesia. Of the 225 participants, 205 completed the study. Based on the AIMS dyskinesia score, results showed valbenazine significantly improved tardive dyskinesia compared with placebo.

Reference:

Hauser RA, et al. KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia. Am J Psych. 2017 May 1;174(5):476-484.

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