Jordan Beveridge, Eileen Kaniecki, Aniketh Naidu, Bret David Silverglate, George Grossberg
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引用次数: 0
摘要
简介针对淀粉样蛋白-β的单克隆抗体是首批获得美国食品及药物管理局批准的阿尔茨海默病疾病改变疗法。目前有三种不同的药物已获批准或正在等待 FDA 批准:阿杜卡单抗(aducanumab)、莱卡内单抗(lecanemab)和多那单抗(donanemab)。这三种药物分别处于美国 FDA 批准的不同监管阶段:我们将讨论这些药物的开发、临床疗效数据、给药方案和副作用。此外,我们还探讨了这些药物作为普通疗法用于延缓阿尔茨海默病衰退速度的可行性问题,以及这一类新药还有哪些未解之谜:我们的结论是,这些以淀粉样蛋白-β为靶点的新型单克隆抗体代表了阿尔茨海默病治疗领域的真正进步,但其临床意义仍存在问题,而且考虑到副作用风险、成本、用药困难和资格确定等因素,哪些患者最能从这些药物中获益。
How promising are the latest monoclonal antibodies targeting amyloid-β for the treatment of early Alzheimer's disease?
Introduction: Monoclonal antibodies targeting amyloid-β are the first disease-modifying treatments for Alzheimer disease to have received FDA-approval. There are three different drugs approved or pending FDA-approval: aducanumab, lecanemab, and donanemab. These three drugs are each in different stages of regulatory approval by the FDA.
Areas covered: We discuss the development of these drugs, the data regarding their clinical efficacy, their dosing regimens, and side effects. In addition, we examine pragmatic issues with their potential implementation as common treatments to slow the rate of decline in Alzheimer disease, and what unanswered questions remain regarding this new class of drugs.
Expert opinion: We conclude that these new monoclonal antibodies that target amyloid-β represent a genuine advance in the treatment of Alzheimer disease. However, questions remain regarding their clinical significance. Additionally, it is presently unclear which patients would most benefit from these expensive drugs given the risk of side effects and the logistical difficulties concerning administration and the determination of eligibility.
期刊介绍:
Expert Opinion on Emerging Drugs (ISSN 1472-8214 [print], 1744-7623 [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing structured reviews on Phase II and Phase III drugs/drug classes emerging onto the market across all therapy areas, providing expert opinion on their potential impact on the current management of specific diseases.