FDA BRIEF: Week of April 10, 2017

FDA approved


INGREZZA (valbenazine) capsules

Neurocrine Biosciences, San Diego, CA

INDICATION:  Treatment of adults with tardive dyskinesia

ADDRESSING UNMET NEED:

  • Neurological disorder characterized by repetitive involuntary movements
  • Can be disabling and can further stigmatize patients with mental illness
  • Serious side effect seen in patients antipsychotic medications
  • First drug for the treatment

REG PATHWAY: NDA

  • Fast Track, Priority Review and Breakthrough Therapy designations.
  • Postmarketing Requirements: In vitro studies, PK studies,  clinical dependence and withdrawal symptom assessment study

MECHANISM OF ACTION: Reversible inhibition of vesicular monoamine transporter 2 (VMAT2) that regulates monoamine uptake from cytoplasm to synaptic vesicle for storage and release

EFFICACY:

  • Randomized, double-blind, placebo-controlled trial, n=234,  patients with moderate to severe tardive dyskinesia, INGREZZA vs. placebo, 6 weeks, then on INGREZZA for 48 weeks
  • Primary efficacy measure: Abnormal Involuntary Movement Scale (AIMS) change from baseline
  • AIMS change  statistically significantly different from placebo; consistent across multiple subgroups

SAFETY:

  • Serious side effects: Sleepiness, QT prolongation.

LABEL


 

 

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