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FDA批准Fintepla治疗Dravet综合征

2020-06-27 Allan MedSci原创

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。

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Dravet综合征患者检测出电压门控钠离子通道α-1亚基基因(SCN1A)突变。该综合征的典型特征是药物难治性癫痫发作,抗癫痫药物治疗的总体疗效有限。尽管如此,应尽可能避免发作诱因,并最大限度地控制发作和癫痫持续状态。

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。该公司指出,Fintepla(芬氟拉明)有望在7月底上市。Zogenix首席执行官Stephen Farr表示:“ Fintepla的批准是Zogenix的重要里程碑”。

Zogenix指出,该批准是基于两项III期研究的数据,结果表明,与现有的治疗方案相比,对于经一种或多种抗癫痫药未充分控制癫痫发作的患者,Fintepla显著降低了癫痫发作频率。此外,大多数患者在3到4周内对Fintepla的治疗有反应,并且在14到15周的治疗期内效果保持一致。

 

原始出处:

https://www.firstwordpharma.com/node/1735753?tsid=4

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    2021-01-15 bugit
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    2020-06-28 zhouqu_8

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