| ——新型癫痫药物Briviact（布立西坦10mg/mL）溶液注射/输液获美国FDA批准 2016年2月19日,美国食品和药品监管局(FDA)批准Briviact (布瓦西坦 brivaracetam)作为添加治疗至其他药物治疗在年龄16岁和以上有癫痫患者部分发作性癫痫[partial onset seizures]。 癫痫是一种脑疾病引起人们有复发性癫痫发作。一个癫痫发作是一种发作[episode]，通常地相对短时间，异常脑活动。癫痫发作可致各种症状，包括不能控制运动或痉挛，异常想法和行为，和异常感觉。肌肉痉挛可能是剧烈，和可能发生丧失意识。癫痫发作发生当在脑中聚集的神经细胞进行不能控制激活。在脑的限定取悦内一个部分发作性癫痫。 FDA药品评价和研究中心中神经学产品部主任Billy Dunn，M.D.说：“患者对可得到的各种癫痫发作药物可能有不同反应，” “随Briviact的批准，I感到高兴患者对癫痫有新治疗选择。” 癫痫有许多可能的原因包括，等等，卒中，感染，肿瘤，创伤性脑损伤，和脑异常发育。在许多病例中，不知道特异性原因。癫痫是影响脑最常见情况之一。在美国约510万人有癫痫史和约290万人有活动性癫痫。 在三项临床试验涉及1,550参加者研究Briviact的有效性。Briviact与其他药物一起被显示减低癫痫发作频数中疗效。 在临床试验中服用Briviact人们最常报道的副作用包括嗜睡，头晕，乏力，恶心和呕吐。 Briviact必须与对患者用药指南一起发放，其中提供关于药物使用和风险重要信息。真实的对所有治疗癫痫药物，最严重风险包括自杀想法，企图自杀，情绪激动，新或抑郁恶化，攻击性，和惊恐发作。罕见地，患者可能表现过敏反应伴随唇，眼睑或舌肿胀有或无呼吸困难。 Briviact由佐治亚Smyrna的UCB公司上市。 Briviact (brivaracetam) 10mg/mL solution for injection/infusion Information type: Drug prescribing Brivaracetamis is licensed as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy. INDICATION BRIVIACT® (brivaracetam) is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy IMPORTANT SAFETY INFORMATION Warnings and Precautions •Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider. •Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Somnolence and fatigue-related adverse reactions were reported in 25% of patients taking at least 50 mg per day of BRIVIACT compared to 14% of patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of patients taking at least 50 mg per day of BRIVIACT compared to 10% of patients taking placebo. The risk is greatest early in treatment but can occur at any time. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT. •Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in approximately 13% of patients taking at least 50 mg per day of BRIVIACT compared to 8% of patients taking placebo. A total of 1.7% of adult patients taking BRIVIACT discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. Advise patients to report these symptoms immediately to a healthcare provider. •Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients. •Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. Adverse Reactions The most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. To report suspected adverse reactions, contact UCB, Inc. at UCBCares™ (1-844-599-2273) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. New Drugs Online Report for brivaracetam Information Generic Name: brivaracetam Trade Name: Briviact Entry Type: New molecular entity Development and Regulatory status UK: Approved (Licensed) EU: Approved (Licensed) US: Pre-registration (Filed) UK launch Plans: Available only to registered users Actual UK launch date: Comments Jan 16: Approved in EU. Launches planned before end of March [12]. 21/01/2016 10:49:07 Nov 15: EU positive opinion for use as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent patients from 16 years of age with epilepsy [10]. 20/11/2015 15:11:29 Oct: 15. Approval anticipated end of 2015, with launch in Q1 2016. (9) 21/10/2015 12:10:03 Jan 15: Filed in both the US and EU for brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in pts from 16 years of age with epilepsy [8]. 22/01/2015 09:16:56 Jul 14: UCB Pharma plan to file in the US & EU in early 2015 [7]. 24/07/2014 09:56:00 March 2014: Long-term safety and tolerability studies (NCT00761774 and NCT01728077) due to complete in mid-2015 and in 2017 respectively. [6] 01/04/2014 15:21:38 Orphan status for progressive myoclonic seizures granted in 2005 in EU and US (1) 29/04/2009 16:18:01 PIII programme started Oct 07 (1) 29/04/2009 16:15:39 Trial or other data Jan 15: Filed in both the US and EU for brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in pts from 16 years of age with epilepsy [8]. 22/01/2015 09:16:10 Jul 14: UCB announce positive topline results from a PIII study designed to evaluate brivaracetam compared to placebo, as adjunctive treatment in adults not fully controlled despite treatment with one or two concomitant antiepileptic drugs. The results showed that brivaracetam reduced partial-onset seizure frequency and improved responder rates [7]. 24/07/2014 09:56:19 NCT01728077 is a PIII to assess the longterm safety and tolerability of brivaracetam tablets (up to 200 mg/day) when used as an adjunctive treatment for epilepsy in 650 patients. It started in Oct 12 and is due to complete Sep 16 [5] 26/03/2013 15:17:05 May 12: August 2011, PIII study as an adjunctive treatment for adults with epilepsy was initiated (N01258; NCT01405508 [4]. 31/05/2012 16:17:18 Apr 09: UCB announced top-line results from 2 PIII 12 week studies of brivaracetam (5, 20, 50 or 100mg daily) as adjunctive treatment of partial-onset seizures in adults with epilepsy, not fully controlled despite treatment with one or two other antiepileptic drugs. The primary endpoint was a statistically superior reduction in seizure frequency vs placebo; study N01253 achieved the primary endpoint, while study N01252 did not. The company reported that the 2 studies, together with a third 16 week safety study (N01254) suggest that the drug is well tolerated with the majority of adverse events reported being mild to moderate in nature. Nearly 1,300 patients, aged between 16 and 70, took part in the three III studies (2). 29/04/2009 16:30:00 Evidence Based Evaluations EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003898/WC500200208.pdf References Available only to registered users Category BNF Category: Control of epilepsy (04.08.01) Pharmacology: Sodium channel antagonist Epidemiology: The incidence of epilepsy is about 50 per 100,000 per annum. The incidence is high in childhood, decreases in adulthood and rises again in older people. The usual prevalence figure given for active epilepsy in the UK is 5-10 cases per 1,000 [3]. Indication: Epilepsy Additional Details: adjunctive treatment for focal seizures Method(s) of Administration Oral Company Information Name: UCB Pharma US Name: UCB Pharma Further Information Anticipated commissioning route (England) NHSE High cost drug list? No Implications Available only to registered users |
美国FDA批准Briviact治疗部分发作性癫痫简介：
新型癫痫药物Briviact（布立西坦10mg/mL）溶液注射/输液获美国FDA批准2016年2月19日,美国食品和药品监管局(FDA)批准Briviact (布瓦西坦 brivaracetam)作为添加治疗至其他药物治疗在年龄16岁和以上有癫痫患 ... 责任编辑：admin
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