Avacopan: First Approval
Avacopan: First Approval
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DOI：
10.1007/s40265-021-01643-6
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发表时间：
2021-11-26
期刊：
影响因子：
11.5
通讯作者：
Lee, Arnold
中科院分区：
文献类型：
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作者：
Lee, Arnold
Avacopan (TAVNEOS (TM)) 是 ChemoCentryx 开发的补体 5a 受体 (C5aR) 拮抗剂，用于治疗自身免疫性疾病，包括抗中性粒细胞胞浆自身抗体 (ANCA) 相关血管炎。 avacopan 的治疗作用归因于对中性粒细胞 C5aR 活性的抑制，然而，对 ANCA 相关血管炎患者的治疗效果的确切机制尚未确定。 2021 年 9 月，avacopan 在日本首次获得批准，用于治疗显微镜下多血管炎 (MPA) 和肉芽肿性多血管炎 (GPA)，这是 ANCA 相关血管炎的两种最常见形式，Kissei Pharmaceutical 正在通过与 Vifor Pharma 合作将其商业化。 2021 年 10 月，avacopan 在美国被批准作为成人严重活动性 ANCA 相关血管炎（特别是 MPA 和 GPA）的辅助治疗，与包括糖皮质激素在内的标准疗法联合使用（avacopan 并不能消除糖皮质激素的使用）。 Avacopan 在欧盟获得了积极评价，同时也在瑞士和加拿大接受监管审查。 Avacopan 正在研究用于治疗补体成分 3 肾小球病、化脓性汗腺炎、狼疮性肾炎和 IgA 肾病。本文总结了 avacopan 在日本和美国首次获得批准的开发里程碑。
Avacopan (TAVNEOS (TM)) is a complement 5a receptor (C5aR) antagonist developed by ChemoCentryx for the treatment of autoimmune diseases including anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. The therapeutic effects of avacopan are attributed to the inhibition of C5aR activity on neutrophils, however, the exact mechanism of therapeutic efficacy in patients with ANCA-associated vasculitis has not been established. In September 2021, avacopan received its first approval in Japan for the treatment of microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA), the two most common forms of ANCA-associated vasculitis, where it is being commercialized by Kissei Pharmaceutical through a partnership with Vifor Pharma. In October 2021, avacopan was approved in the USA as an adjunctive treatment in adults for severe active ANCA-associated vasculitis (specifically MPA and GPA) in combination with standard therapy including glucocorticoids (avacopan does not eliminate glucocorticoid use). Avacopan has received a positive opinion in the EU, and is also undergoing regulatory review in Switzerland and Canada. Avacopan is being investigated for the treatment of complement component 3 glomerulopathy, hidradenitis suppurativa, lupus nephritis and IgA nephropathy. This article summarizes the milestones in the development of avacopan leading to these first approvals in Japan and the USA.