卫材在法国推出新一代抗癫痫药Fycompa

卫材在法国推出新一代抗癫痫药Fycompa

来源：生物谷 2014-05-23 09:12

                               
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2014年5月22日讯 /生物谷BIOON/ --卫材（Eisai）5月22日宣布，已收到法国健康产品经济委员会（CEPS）对新一代癫痫药物Fycompa（perampanel）的报销批准，公司将在法国推出该药，使法国的癫痫群体受益。Fycompa于2012年7月获欧盟批准，用于12岁及以上成人癫痫患者患有或无继发性全身性发作、部分癫痫发作的辅助治疗。

Fycompa的获批，是基于3项关键性、全球性、随机、双盲、安慰剂对照、剂量递增、涉及1480例癫痫患者的III期研究的临床资料。每一项研究均证明了perampane在辅助治疗部分发作性癫痫患者中的疗效及良好耐受性。研究所报道的最常见不良事件包括头晕、头痛、嗜睡、烦躁、乏力及共济失调。

Fycompa由卫材发现和开发，是一种高度选择性、非竞争性的AMPA型谷氨酸受体拮抗剂。谷氨酸是介导癫痫发作的主要神经递质。作为AMPA受体拮抗剂，Fycompa能通过靶向突触后AMPA受体-谷氨酸的活动，减少与癫痫发作相关神经元的过度兴奋。这种作用机制，与目前市售的抗癫痫药物（AEDs）不同，这意味着Fycompa是这类新药中获欧盟批用于成人及12岁以上青少年癫痫患者的首个AED药物。

Fycompa具有日服一次的益处，有望减少潜在的服药负担，并改善患者的药物依从性。

癫痫是全球最常见的神经系统疾病之一。在法国约有45万例癫痫患者，每天新诊100例。癫痫发作是大脑神经元激发和抑制不平衡的结果，这些不平衡可能通过多种神经化学机制引发，但目前知之甚少。（生物谷Bioon.com）

英文原文：Eisai launches new class of epilepsy treatment Fycompa in France

Published on May 22, 2014 at 5:56 AM

Fycompa® (perampanel), the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), has today received reimbursement approval from the Comité Economique des Produits de Santé (CEPS). The therapy is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.

Perampanel is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, a protein in the brain which plays a fundamental role in the spread of seizures. This mechanism of action of perampanel is different to other, currently available AEDs. In addition, perampanel has the added benefit of convenient, once-daily dosing at bedtime, in a single tablet irrespective of dosage. Perampanel is also the only new-generation partial epilepsy treatment approved to treat adolescents aged 12 and above.

Epilepsy is one of the most common neurological conditions in the world. Around 450,000 people in France live with the condition, with over 100 new cases diagnosed each day. Seizures are the result of an imbalance between inhibition and excitation of neurons in the brain. These imbalances between excitation and inhibition can be caused by various neurochemical mechanisms which are still often poorly understood. Seizures can be triggered by numerous causes: scars from a stroke, cranial traumas, infections, genetic diseases, tumours, malformations. For these reasons there are several types of AEDs with different targets of action, and patients have variable sensitivity to treatment. Thus, about one third of patients are resistant to available treatments and require new therapeutic intervention.

“New treatment options like perampanel becoming available is a very important event for people with partial onset epilepsy in France who live with uncontrolled seizures, and for the physicians who treat them,” said Arnaud Biraben, Neurologist and Epileptologist, Rennes University Hospital, France and President of The French League Against Epilepsy.

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