Aducanumab: evidence from clinical trial data and controversies

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Abstract

Alzheimer’s disease (AD) is the most common cause for dementia worldwide. Until recently, all approved treatments for AD were symptomatic and not disease modifying. On 7 June 2021, the US FDA approved aducanumab, a human IgG1 anti-Aβ monoclonal antibody selective for Aβ aggregates, as the first disease-modifying treatment for AD. Aducanumab is approved in the United States for the treatment of mild cognitive impairment or mild-dementia stage of AD. In this Editorial, we review the trial data for aducanumab in the treatment of AD and the controversies that its approval has generated.

Keywords: β-amyloid, aducanumab, Alzheimer’s disease, amyloid-related imaging abnormalities, anti-Aβ monoclonal antibody, dementia, neurofibrillary tangles, tau proteins.

Citation: Tampi RR, Forester BP, Agronin M. Aducanumab: evidence from clinical trial data and controversies. Drugs Context. 2021;10:2021-7-3. https://doi.org/10.7573/dic.2021-7-3

Contributions: RRT completed the literature search, reviewed the data and wrote the initial draft of the manuscript. BF and MA reviewed the draft of the manuscript and made suggestions/additions/corrections to it. RRT completed the final revisions on the manuscript. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: RRT has none. BF reports grants and other from Biogen during the conduct of the study and grants from Lilly, Eisai, NIH, Rogers Family Foundation and Spier Family Foundation and other from Acadia Pharmaceuticals, outside the submitted work. MA reports consulting for Biogen, Otsuka and Eli Lilly. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2021/09/dic.2021-7-3-COI.pdf

Acknowledgements: None.

Funding declaration: There was no funding associated with the preparation of this article.

Copyright: Copyright © 2021 Tampi RR, Forester BP, Agronin M. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2021 Tampi RR, Forester BP, Agronin M. https://doi.org/10.7573/dic.2021-7-3. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://www.drugsincontext.com/aducanumab-evidence-from-clinical-trial-data-and-controversies

Correspondence: Rajesh R Tampi, Department of Psychiatry & Behavioral Sciences, Cleveland Clinic Akron General, Akron, Ohio, 44307, USA. Email: rajesh.tampi@gmail.com

Provenance: Invited; externally peer reviewed.

Submitted: 13 July 2021; Accepted: 6 September 2021; Publication date: 4 October 2021.

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