Atrasentan: First Approval

Susan J. Keam

doi:10.1007/s40265-025-02208-7

2025-08-04

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Susan J. Keam *

DOI：10.1007/s40265-025-02208-7

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阿他沙坦（VANRAFIA®），一种强效、高度选择性、口服给药的血管内皮素A（ETA）受体拮抗剂，由诺华公司开发用于治疗肾小球疾病。2025年4月，阿他沙坦在美国获得批准（基于蛋白尿减少的加速审批）以降低原发性IgA肾病（IgAN）成人患者的蛋白尿水平，这些患者存在快速疾病进展风险，通常指尿蛋白肌酐比值（UPCR）≥1.5 g/g。目前尚未确定阿他沙坦能否延缓IgAN患者的肾功能下降。本文总结了阿他沙坦开发过程中的重要里程碑，这些里程碑促成了其首次批准用于降低存在快速疾病进展风险的成人原发性IgAN患者的蛋白尿水平。

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