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阿杜卡努单抗:获批两年后的观察。

Aducanumab: A look two years after its approval.

机构信息

Programa Neurología Clínica, Universidad del Sinú, Cartagena, Colombia.

Grupo de Investigación Neurociencia y Salud Global, Facultad de Medicina, Universidad de Cartagena, Cartagena, Colombia.

出版信息

Biomedica. 2024 May 31;44(Sp. 1):42-46. doi: 10.7705/biomedica.6967.

Abstract

Alzheimer’s disease is the leading cause of dementia worldwide and a critical public health problem. While deaths from cardiovascular diseases have decreased, those attributed to Alzheimer’s disease have increased in recent years with no curative treatment to date. In this context, effective treatment development has become a global priority. Aducanumab is a human anti-amyloid β monoclonal antibody approved by the FDA in June 2021 for the treatment of Alzheimer’s disease but failed to show the expected clinical efficacy in phase III trials. This review analyzes the history of its controversial acceptance, implications, and prospects for future treatment.

摘要

阿尔茨海默病是全球范围内导致痴呆的主要原因,也是一个严重的公共卫生问题。虽然心血管疾病导致的死亡人数有所下降,但近年来归因于阿尔茨海默病的死亡人数却有所增加,而且目前尚无治愈方法。在这种情况下,有效治疗方法的开发已成为全球的首要任务。Aducanumab 是一种人源抗淀粉样蛋白β单克隆抗体,于 2021 年 6 月获得 FDA 批准用于治疗阿尔茨海默病,但在 III 期临床试验中并未显示出预期的临床疗效。本文回顾分析了其备受争议的获批历程、意义及其对未来治疗的展望。

相似文献

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Aducanumab: A look two years after its approval.阿杜卡努单抗:获批两年后的观察。
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Aducanumab for Alzheimer's disease: A regulatory perspective.阿杜卡奴单抗治疗阿尔茨海默病:监管视角。
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Aducanumab: First Approval.阿杜卡奴单抗:首次获批
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本文引用的文献

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2023 Alzheimer's disease facts and figures.2023 年阿尔茨海默病事实和数据。
Alzheimers Dement. 2023 Apr;19(4):1598-1695. doi: 10.1002/alz.13016. Epub 2023 Mar 14.
3
Challenges in Implementing Futility Schemes, with Reference to Aducanumab.实施无效方案的挑战,参考阿杜卡单抗
Ther Innov Regul Sci. 2023 May;57(3):515-520. doi: 10.1007/s43441-023-00499-0. Epub 2023 Feb 3.

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