FDA的药品评价和研究中心内精神产品部主任Mitchell Mathis，M.D.说："迟发性运动障碍可能正在残疾和可能进一步使有精神疾患患者感到羞耻[stigmatize 患者]，"批准首个为迟发性运动障碍治疗的药物对患这种情况患者是一个重要进展。"
● 初始剂量是40 mg每天1次。一周后，增加剂量至推荐剂量的80 mg每天1次。
● QT延长：可能致QT间期延长。有先天性长T 综合证或有心律失常伴随延长QT间期患者避免使用.
Neurocrine Announces INGREZZA™ (valbenazine) New Drug Application for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by U.S. FDA
11, 2016 U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (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.
"This is another significant milestone for Neurocrine and more importantly those patients who are suffering from tardive dyskinesia," said Kevin C. Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "We will continue to work with the FDA in their review of the INGREZZA NDA to potentially bring this important treatment option to patients and physicians."
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.
About Tardive Dyskinesia
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.
VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in pre-synaptic neurons. INGREZZA (valbenazine or NBI-98854), developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication, showing little or no affinity for VMAT1, other receptors, transporters and ion channels. INGREZZA is designed to provide low, sustained, plasma and brain concentrations of active drug to allow for once daily dosing.
Modulation of neuronal dopamine levels in diseases such as tardive dyskinesia, Tourette syndrome, Huntington's chorea, schizophrenia, and tardive dystonia, which are characterized, in part, by a hyperdopaminergic state, may provide symptomatic benefits for patients with these diseases.
Neurocrine received Breakthrough Therapy Designation from the FDA in 2014 for INGREZZA in the treatment of tardive dyskinesia. The NDA for INGREZZA for the treatment of tardive dyskinesia is currently under Priority Review with the FDA. The proprietary name INGREZZA has been conditionally accepted by the FDA.