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欧盟批准Fintepla治疗Dravet综合征

2020-12-29 Allan MedSci原创

欧盟SCN1ADravet综合征ZogenixFintepla
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Dravet综合征是一种罕见的儿童遗传性癫痫综合征，其特征是从婴儿期开始出现的难治性癫痫以及神经发育问题。70%-80%的DS患者检测出电压门控钠离子通道α-1亚基基因(SCN1A)突变。

Dravet综合征是一种罕见的儿童遗传性癫痫综合征，其特征是从婴儿期开始出现的难治性癫痫以及神经发育问题。70%-80%的DS患者检测出电压门控钠离子通道α-1亚基基因(SCN1A)突变。

欧盟委员会（EC）已批准Zogenix的Fintepla（芬氟拉明）用于治疗与Dravet综合征相关的癫痫发作，Fintepla（芬氟拉明）可作为其他抗癫痫药的附加疗法。

该批准是基于两项III期临床试验的阳性安全性和有效性结果，以及对330名Dravet综合征患者长达三年的进行的长期扩展研究。在这些研究中，发现Fintepla当与其他抗癫痫疗法结合使用时，可显著降低惊厥性癫痫发作频率，具有统计学意义和临床意义。最常见的副作用包括食欲下降、腹泻、发热、疲劳、上呼吸道感染、嗜睡和支气管炎。

Zogenix总裁兼首席执行官Stephen Farr表示：“有了EMA的批准，Fintepla将更加广泛地用于欧洲Dravet综合征患者”。

于今年早些时候，Fintepla还获得了美国食品药品监督管理局（FDA）的批准，用于治疗Dravet综合征相关的癫痫发作。

 

原始出处：

http://www.pharmatimes.com/news/eu_green_light_for_zogenixs_fintepla_1360479

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    2021-01-23 xiaoshitou

    #Fintepla#

    0

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    2020-12-31 zhang92560

    #Dravet综合征#

    0

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    2020-12-31 zhouqu_8

    #综合征#

    0

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    2020-12-31 heli0118

    #欧盟批准#

    0

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    2020-12-29 ms2000001051330459

    学习了，涨知识了！

    0

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拓展阅读

Dravet综合征：一种可治疗的罕见病

Dravet综合征（Dravet syndrome, DS），原称婴儿严重肌阵挛癫痫(severe myoclonic epilepsy of infancy，SMEI)，因本病有25%的患儿始终不出

Neurology：大龄Dravet综合征患者步态和运动异常进行性恶化

Dravet综合征是一种难治性、发育性和癫痫性脑病。近日，研究人员检查了患有DS的老年人的步态和运动表现，发现尽管患有DS的老年人的癫痫发作可能会减少，但其运动症状和步态随着年龄增长而逐渐恶化。

FINTEPLA（芬氟拉明）治疗Dravet综合征的癫痫发作：CHMP持正面评价

欧洲药品管理局（EMA）的人用药品委员会（CHMP）建议授予FINTEPLA®（芬氟拉明）市场营销许可，以治疗与Dravet综合征相关的癫痫发作。

EPX-100治疗Dravet综合征：II期研究已经启动

Dravet综合征是一种罕见的儿童遗传性癫痫综合征，其特征是从婴儿期开始出现的难治性癫痫以及神经发育问题。70%-80%的DS患者检测出电压门控钠离子通道α-1亚基基因(SCN1A)突变。

FDA批准Fintepla治疗Dravet综合征

制药公司Zogenix宣布，FDA已批准Fintepla（芬氟拉明）治疗两岁及以上Dravet综合征患者的癫痫发作。

JAMA Neurol：大麻二酚可降低Dravet综合征导致的抽搐发作频率

大麻二酚可降低耐药性Dravet综合征导致的抽搐发作频率