Istradefylline: First Global Approval
Istradefylline: First Global Approval
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DOI：
10.1007/s40265-013-0066-7
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发表时间：
2013-06-01
期刊：
影响因子：
11.5
通讯作者：
Deeks, Emma D.
中科院分区：
文献类型：
--
作者：
Dungo, Rosselle;Deeks, Emma D.
Kyowa Hakko Kirin 正在开发 istradefylline，一种选择性腺苷 A(2A) 受体拮抗剂，用于每日一次口服治疗帕金森病 (PD)。腺苷 A(2A) 受体被认为特别存在于大脑的基底神经节中； PD 中观察到的变性或异常被认为发生在基底神经节中，基底神经节被认为在运动控制中发挥着重要作用。市售的多巴胺替代疗法可有效治疗帕金森病的早期运动症状；然而，这些药物与运动并发症的发生有关，限制了疾病晚期的用途。伊曲茶碱被认为与作用于多巴胺代谢或多巴胺受体的现有药物具有明显不同的作用位点。 Kyowa Hakko Kirin 已在日本获得批准伊曲茶碱用于 PD 的辅助治疗。美国已提交新药申请，但 FDA 于 2008 年 2 月发出了一封未批准函。本文总结了伊曲茶碱开发过程中的里程碑，导致其首次获批用于治疗 PD 患者。
Kyowa Hakko Kirin is developing istradefylline, a selective adenosine A(2A) receptor antagonist, for the once-daily oral treatment of Parkinson's disease (PD). Adenosine A(2A) receptors are considered to be present particularly in the basal ganglia of the brain; the degeneration or abnormality observed in PD is believed to occur in the basal ganglia, which is recognized to play a significant role in motor control. Commercially available dopamine replacement therapies effectively treat the early motor symptoms of PD; however, these agents are associated with development of motor complications, limiting usefulness in late stages of the disease. Istradefylline is proposed to possess a clearly distinct action site from existing agents which act on dopamine metabolism or dopamine receptors. Kyowa Hakko Kirin has received approval for istradefylline in the adjunctive treatment of PD in Japan. A New Drug Application was filed in the USA, but the FDA issued a non-approvable letter in February 2008. This article summarizes the milestones in the development of istradefylline leading to its first approval for the treatment of patients with PD.