2017年4月11日，美国食品和药品监管局今天批准Ingrezza(valbenazine)胶囊治疗成年有迟发性运动障碍。这是对这种情况批准的首个药物。 迟发性运动障碍是一种神经学疾患特征是重复性的不自主运动，通常下颚，唇和舌，例如扮鬼脸，伸出舌和smacking唇。有些受影响人经受不自主肢体运动或呼吸困难。. 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 patients]，""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。" 迟发性运动障碍是一种严重的副作用有时在患者曽用抗精神病药物治疗患者中见到，尤其是老药，对长阶段治疗慢性情况，例如精神分裂和躁狂抑郁性精神病[bipolar disorder]。 迟发性运动障碍也可能发生在为抑郁症用抗精神病药物患者和某些对胃肠道疾患药物和其他情况。 在一项234参加者比较Ingrezza与placebo临床试验显示Ingrezza的疗效。在6周后，接受Ingrezza参加者异常不自主运动的严重程度与接受安慰剂参加者比较有改善。 Ingrezza可能致严重的副作用包括嗜睡和心脏节律问题(QT延长)。在有先天性QT综合证或有异常心跳伴随一个延长的QT间期患者应避免它的使用。用Ingrezza患者不应驾驶或操作重型机械或做其他危害性活动直至他已知药物如何影响他们。 FDA授权这项申请快速通道，优先审评和突破性治疗指定。 FDA赋予Ingrezza的批准至Neurocrine Biosciences，Inc. Ingrezza,(valbenazine MT-5199, NBI-98854) 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. "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. About INGREZZA 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. Ingrezza will be available as 40mg strength capsules in 30- and 90-count bottles. It will be available through a select pharmacy network starting next week. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm552418.htm