You are here

Article Text

Article menu
Download PDFPDF
Editorial
Aducanumab for Alzheimer’s disease – too many unanswered questions
  1. David Phizackerley, Deputy Editor
  1. DTB, BMJ Journals, London, UK
  1. Correspondence to Mr David Phizackerley, Deputy Editor, DTB, BMJ Journals, London, UK; dphizackerley{at}bmj.com

https://doi.org/10.1136/dtb.2021.000043

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    In June 2021, the US Food and Drug Administration (FDA) announced that it had approved aducanumab for the treatment of Alzheimer’s disease.1 The FDA used its accelerated approval process, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a marker of the disease rather than a patient-oriented outcome. In this case, the approval decision was based on levels of amyloid-beta in the brain, an unvalidated surrogate marker. A recent review has called into question evidence linking this surrogate marker to an effect on cognitive function.2 Furthermore, in November 2020, the specialist committee that advised the FDA on this application had noted that while the drug has some effect on amyloid pathology, 10 of its 11 members …

    View Full Text

    Footnotes

    • Competing interests None declared. Refer to the online supplementary files to view the ICMJE form(s).

    • Provenance and peer review Commissioned; externally peer reviewed.