Neurocrine: FDA Accepts For Priority Review INGREZZA NDA In Tardive Dyskinesia

(RTTNews) - Neurocrine Biosciences, Inc. (NBIX) announced Tuesday that the U.S. Food and Drug Administration or FDA has accepted for Priority Review the New Drug Application or NDA for INGREZZATM (valbenazine) for the treatment of tardive dyskinesia.

The INGREZZA application has been given a Prescription Drug User Fee Act or PDUFA target action date of April 11, 2017.

INGREZZA (valbenazine or NBI-98854), developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication.

The NDA for INGREZZA includes the results from the Kinect 2 and Kinect 3 clinical trials which evaluated over 330 tardive dyskinesia patients. Data from these studies along with the results from another 18 clinical trials, extensive preclinical testing and drug manufacturing data were included in the NDA submission.

The company noted that a Priority Review designation accelerates the FDA review timeline from 10 months to 6 months from the date of acceptance of the NDA.

INGREZZA (valbenazine) previously received Fast Track status and Breakthrough Designation status from the FDA.

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