Neurocrine Says FDA Cancels Psychopharmacologic Drugs Advisory Committee Meeting

(RTTNews) - Neurocrine Biosciences Inc. (NBIX) said that the U.S. Food and Drug Administration, after further review of the INGREZZA (valbenazine) New Drug Application (NDA), has decided to cancel the Psychopharmacologic Drugs Advisory Committee meeting which was originally scheduled for February 16, 2017.

The FDA informed the Company that the Priority Review of the NDA of INGREZZA for the treatment of tardive dyskinesia is continuing as planned with the previously announced Prescription Drug User Fee Act (PDUFA) target action date of April 11, 2017.

The NDA for INGREZZA includes the results from the Kinect 2 and Kinect 3 clinical trials along with the results from another 18 clinical trials; extensive preclinical testing and drug manufacturing data were included in the NDA submission. The FDA granted Breakthrough Therapy Designation to INGREZZA for tardive dyskinesia in 2014.