Neurocrine Biosciences, Inc. (NASDAQ:NBIX) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”) has accepted for priority review the New Drug Application (the “NDA”) for INGREZZATM (valbenazine) for the treatment of tardive dyskinesia. The INGREZZA application has been given a Prescription Drug User Fee Act (PDUFA) target action date of April 11, 2017.
The FDA has not notified the Company of a date for an advisory committee meeting, if any, relating to the NDA.
A Priority Review designation accelerates the FDA review timeline from 10 months to 6 months from the date of acceptance of the NDA. The designation directs the FDA’s overall attention and resources to the evaluation of applications for drugs that, if approved, would be a significant improvement in the safety or effectiveness of the treatment of a serious condition. INGREZZA (valbenazine) previously received Fast Track status and Breakthrough Designation status from the FDA.
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.