EMA接受抗部分性癫痫发作药物cenobamate的销售授权申请

2020-04-04 MedSci原创 MedSci原创

Cenobamate的营销申请是基于一项全球临床试验计划,该计划招募了1900名不受控制的部分性癫痫发作成人患者。

欧洲药品管理局(EMA)已经接受了抗癫痫药cenobamate的营销授权申请(MAA),用于部分性癫痫发作成人患者的辅助治疗。

Cenobamate是由SK Biopharmaceuticals开发,该公司开展了两项全球性、随机、双盲、安慰剂对照研究和一项大型全球性、多中心、开放标签的安全性研究。这三项研究招募了1900多名不受控制的部分性癫痫发作成人患者。

Cenobamate已被美国食品和药物管理局(FDA)批准用于治疗部分性癫痫发作的成人患者。在美国,cenobamate片剂预计将在2020年第二季度上市。

该药物的具体作用机理尚未确定,然而普遍认为cenobamate是通过抑制电压门控钠通道和作为γ-氨基丁酸(GABAA)离子通道的正变构调节剂来减少重复性神经元放电,进而发挥治疗作用。

多个临床试验正在研究cenobamate在其他发作类型的癫痫中是否有效。

原始出处:

https://www.europeanpharmaceuticalreview.com/news/116241/ema-accepts-marketing-authorisation-application-for-anti-epileptic-drug-cenobamate/

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    2020-10-13 zsyan
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    2020-04-06 fengyi812

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