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氘代药物Austedo (deutetrabenazine)的研发案例分析
氘代药物Austedo (deutetrabenazine)的研发案例分析
高广花,王海学

国家食品药品监督管理总局药品审评中心,北京 100038
Research & development of Austedo (deutetrabenazine): a case study
(Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038, China)

摘要参考文献相关文章

起始页:2159

摘要:[摘要] Austedo为FDA最近批准的治疗亨廷顿舞蹈症的新药,也是首个按氘代药物研发上市的新药,参比药物为已上市的丁苯那嗪,以505(b)2 类别提交资料。本品研发与评价中重点关注了药动学中代谢物种类及暴露水平的比较研究,最终获得了上市批准。本文就申请人提交的非临床及临床研发证据,介绍了FDA对此类新药的关注点及审评思路,希望对今后同类药的审评提供借鉴信息。

关键词:[关键词] Austedo;亨廷顿舞蹈症;氘代丁苯那嗪; 药动学;桥接;审评

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Abstract:[Abstract] Austedo was approved recently by FDA as a first deuterated new drug submitted in the class of 505(b) (2), using the marketed tetrabenazine (TBZ) as the reference listed drug, for the treatment of chorea due to Huntington's disease (HD). Austedo experienced two cycles of NDA evaluation by FDA, and the major concern was the metabolite exposure difference between Austedo and TBZ, which was the critical factor for the bridging of the available data. The submitted nonclinical and clinical evidences were analyzed in this paper based on the FDA review reports, which may be helpful for the future evaluation of similar new drug submission.

Key words:[Key words] Austedo; Chorea due to Huntington's disease; deutetrabenazine; pharmacokinetics; bridge; evaluation

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