BioCentury
ARTICLE | Company News

Priority Review for Neurocrine's valbenazine

October 11, 2016 7:00 AM UTC

Neurocrine Biosciences Inc. (NASDAQ:NBIX) said FDA accepted and granted Priority Review to an NDA for Ingrezza valbenazine to treat tardive dyskinesia. Its PDUFA date is April 11, 2017.

Last year, the selective vesicular monoamine transporter 2 (VMAT2; SLC18A2) inhibitor met the primary endpoint in a Phase III study in the indication, for which the compound has breakthrough therapy designation (see BioCentury Extra, Oct. 8, 2015). ...