The FDA, after further review of the new drug application (NDA) for valbenazine (Ingrezza, Neurocrine Biosciences), has decided to cancel a meeting of its Psychopharmacologic Drugs Advisory Committee that was scheduled for February 16, 2017. The FDA informed Neurocrine, however, that the priority review of the NDA for valbenazine for the treatment of patients with tardive dyskinesia is continuing as planned, with the previously announced target action date of April 11, 2017.
The NDA for valbenazine included results from the Kinect 2 and Kinect 3 trials along with findings from an additional 18 clinical studies; extensive preclinical testing and drug manufacturing data were also included in the submission. The FDA granted a breakthrough therapy designation to valbenazine for tardive dyskinesia in 2014.
Vesicular monoamine transporter 2 (VMAT2) is a protein concentrated in the human brain that is primarily responsible for repackaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in presynaptic neurons. Valbenazine is a highly selective VMAT2 inhibitor that modulates dopamine release during nerve communication, showing little or no affinity for VMAT1 or for other receptors, transporters, and ion channels. Valbenazine is designed to provide low, sustained plasma and brain concentrations of active drug to allow once-daily dosing. The proprietary name Ingrezza has been conditionally accepted by the FDA.
Tardive dyskinesia is characterized by involuntary, repetitive movements of the face, trunk, or extremities, including lip smacking, grimacing, tongue protrusion, facial movements, blinking, and puckering and pursing of the lips. These symptoms are rarely reversible, and there are no FDA-approved treatments.
Source: Neurocrine Biosciences; January 5, 2017.