Aducanumab for Alzheimer's disease: A regulatory perspective

被引：43

作者：

Nistico, Robert ^{[1
,2
]}

Borg, John Joseph ^{[1
,3
]}

机构：

[1] Univ Tor Vergata, Sch Pharm, Dept Biol, Rome, Italy

[2] Fdn EBRI Rita Levi Montalcini, Lab Pharmacol Synapt Plastic, Rome, Italy

[3] Malta Med Author, Malta Life Sci Pk, San Gwann Sgn 3000, Malta

来源：

PHARMACOLOGICAL RESEARCH | 2021年 / 171卷

关键词：

Alzheimer's disease; Aducanumab; Surrogate marker; Conditional marketing approval; European Medicines Agency; Food and Drug Administration;

D O I：

10.1016/j.phrs.2021.105754

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

On June 7th 2021, the Food and Drug Administration (FDA) granted approval for Aduhelm (aducanumab) for the treatment of Alzheimer's disease under its accelerated approval program. Aducanumab is the first putative disease-modifying therapy (DMT) approved for the treatment of AD with a great potential for clinical benefit over current symptomatic therapies. The scientific community has been largely confounded by this historical decision since this has been based on the reduction of a surrogate marker (amyloid beta) and not on data showing clinical efficacy. Here we provide a regulatory perspective on the topic and discuss potential similarities and differences between the FDA's and EMA's evaluative processes.

引用

页数：3

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