美国FDA批准18年来首款阿尔茨海默病新药，这意味着什么？( 三 )

在2期临床试验中，作用机制多样化的趋势更为明显，55种改变疾病进程的在研疗法中只有20%靶向淀粉样蛋白。
“FDA的这项批准开辟了AD治疗和研究的一个新时代。 ”阿尔茨海默病协会（Alzheimer’s Association）首席执行官Maria C. Carrillo博士说：“历史告诉我们，首个新类型药物的获批会激励整个领域，激发对创新疗法的投入和鼓励更大创新。我们期待，今天的批准，无论对于这款新药还是为阿尔茨海默病患者开发更好的疗法来说，都只是一个开始。 ”
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 注：本文旨在介绍医药健康研究进展，不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。
版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。
【美国FDA批准18年来首款阿尔茨海默病新药，这意味着什么？】本文为***作者原创，未经授权不得转载