The FDA granted Priority Review for Ingrezza (valbenazine), developed by Neurocrine Biosciences for the treatment of tardive dyskinesia. The agency set a PDUFA target action date of April 11, 2017.

Ingrezza is a selective VMAT2 inhibitor that modulates dopamine release during nerve communication, showing little or no affinity for other receptors, transporters and ion channels. Ingrezza previously received Fast Track status and Breakthrough Designation status from the FDA.

The NDA for Ingrezza includes the results from two clinical trials that evaluated more than 330 patients. The symptoms of tardive dyskinesia are rarely reversible and there are currently no FDA-approved treatments, according to Neurocrine, which is also investigating Ingrezza in the treatment of Tourette’s syndrome in two ongoing, placebo-controlled, Phase II studies in adults and children.