FDA批准大麻二酚用于治疗难治性癫痫的审评思路分析

FDA于2018年6月25日批准Epidiolex口服溶液用于治疗难治性癫痫,其活性成分是来源于大麻的高纯度原料大麻二酚。本文通过对FDA关于Epidiolex的审评过程进行分析,结合其审评制度探索FDA在人用经验、化学制造和控制(chemistry,manufacturing,and control,CMC)、非临床、临床等方面的审评思路。同时对FDA关于植物来源高纯度药物审评的重点及特点进行阐述,目的是为我国天然药物研究和技术审评提供有益的参考。

Analysis of FDA assessment consideration on cannabidiol indicated for refractory epilepsy

FDA approved a new drug Epidiolex Oral Solution on June 25,2018 for the treatment of refractory epilepsy.The active ingredient,cannabinol,is a highly purified drug substance derived from the plant Cannabis sativa.This article is to explore FDA assessment consideration on human experience,CMC,non-clinical and clinical by analysis of assessment process and system with Epidiolex.In addition,we also describe FDA’s highlight and characteristics in assessing highly purified plant-derived drugs in order to provide a useful reference for the research and technical assessment on natural medicines in China.