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还需进行确认性试验
▲渤健的Aduhelm在两项3期临床试验中以剂量和时间依赖性方式降低患者大脑中的淀粉样斑块水平(图片来源:渤健官网) 还有哪些疗法具有类似机理?
超越淀粉样蛋白,多款新机制疗法正在开发中
▲处于3期临床试验阶段的AD在研疗法具有多种不同的作用机制(图片来源:参考资料[5])
参考资料:
[1] FDA’s Decision to Approve New Treatment for Alzheimer’s Disease. Retrieved June 7, 2021, from https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease
[2] Alzheimer's Association Welcomes FDA Approval of Aducanumab. Retrieved June 7, 2021, from https://www.alz.org/news/2021/alzheimers-association-welcomes-fda-approval-of-ad
[3] Alzheimer's Drug Discovery Foundation Statement on FDA Approval of Aducanumab. Retrieved June 7, 2021, from https://www.prnewswire.com/news-releases/alzheimers-drug-discovery-foundation-statement-on-fda-approval-of-aducanumab-301306963.html
[4] 2021 ALZHEIMER’S DISEASE FACTS AND FIGURES. Retrieved June 7, 2021, from https://www.alz.org/media/documents/alzheimers-facts-and-figures.pdf
[5] Cummings et al., (2020). Alzheimer’s disease drug development pipeline: 2020. Translational Research & Clinical Interventions. DOI: 10.1002/trc2.12050
[6] FDA Grants Accelerated Approval for Alzheimer's Drug. Retrieved June 7, 2021, from https://www.prnewswire.com/news-releases/fda-grants-accelerated-approval-for-alzheimers-drug-301306966.html
[7] FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease. Retrieved June 7, 2021, from https://www.globenewswire.com/news-release/2021/06/07/2243019/0/en/FDA-grants-accelerated-approval-for-ADUHELM-as-the-first-and-only-Alzheimer-s-disease-treatment-to-address-a-defining-pathology-of-the-disease.html
[8] Mintun et al., (2021). Donanemab in Early Alzheimer’s Disease. NEJM, DOI: 10.1056/NEJMoa2100708
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