Tardive Dyskinesia Drug Valbenazine Set for FDA Review

Nervous-system disorder has no approved treatments

The FDA’s Psychopharmacologic Drugs Advisory Committee has agreed to review data included in the new drug application (NDA) for valbenazine (Ingrezza, Neurocrine Biosciences) for the treatment of patients with tardive dyskinesia on February 16, 2017. The FDA has granted priority review status to the NDA, with a target action date of April 11, 2017.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the face, trunk, or extremities, including lip smacking, grimacing, tongue protrusion, facial movements, blinking, and puckering or pursing of the lips. These symptoms are rarely reversible, and there are no FDA-approved treatments.

VMAT2 is a protein in the human brain that is primarily responsible for repackaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in presynaptic neurons. Valbenazine is a highly selective VMAT2 inhibitor that modulates dopamine release during nerve communication, showing little or no affinity for VMAT1, other receptors, transporters, or ion channels. Valbenazine is designed to provide low, sustained plasma and brain concentrations of active drug to allow once-daily dosing, according to the medication’s developer.

The modulation of neuronal dopamine levels in diseases such as tardive dyskinesia, Tourette syndrome, Huntington’s chorea, schizophrenia, and tardive dystonia––which are characterized, in part, by a hyperdopaminergic state––may provide symptomatic benefits for patients with these diseases.

Valbenazine received a breakthrough therapy designation from the FDA in 2014 for the treatment of tardive dyskinesia. The NDA for valbenazine for the treatment of tardive dyskinesia is currently under priority review. The proprietary name Ingrezza has been conditionally accepted by the agency.

Source: Neurocrine Biosciences; November 29, 2016.