Consensus Statement Regarding the Application of Biogen to Health Canada for Approval of Aducanumab

Authors

  • Howard Chertkow Baycrest Health Sciences; University of Toronto; McGill University
  • Kenneth Rockwood Nova Scotia Health; Dalhousie University
  • David B. Hogan Cumming School of Medicine and O’Brien Institute for Public Health, University of Calgary
  • Natalie Phillips McGill University; Concordia University
  • Manuel Montero-Odasso University of Western Ontario; Gait & Brain Lab at Parkwood Institute; The Lawson Health Research Institute
  • Shabbir Amanullah Woodstock General Hospital
  • Sandra Black Sunnybrook Health Sciences Centre, University of Toronto; Dr. Sandra Black Centre for Brain Resilience and Recovery
  • Christian Bocti Université de Sherbrooke
  • Michael Borrie Western University
  • Howard Feldman Alzheimer Disease Cooperative Study and Alzheimer’s and Related Neurodegenerative Research, University of California San Diego
  • Morris Freedman Baycrest; University of Toronto
  • Robin Hsiung University of British Columbia
  • Andrew Kirk University of Saskatchewan
  • Mario Masellis Sunnybrook Health Sciences Centre, University of Toronto; Centre for Addiction and Mental Health
  • Haakon Nygaard The University of British Columbia
  • Tarek Rajji University of Toronto; Centre for Addiction and Mental Health
  • Louis Verret Université Laval

DOI:

https://doi.org/10.5770/cgj.24.570

Keywords:

aducanumab, Alzheimer's disease, drug therapy

Abstract

Alzheimer’s disease is a major cause of morbidity and mortality. Currently, there are no disease-modifying pharmacotherapies for this condition. Aducanumab, an amyloid beta-directed monoclonal antibody that targets aggregated forms of amyloid-beta in the brains of people with Alzheimer’s disease, has raised hopes that such a therapy has been discovered, but its approval by the US Food and Drug Administration has engendered a good deal of controversy. A similar application for approval has been submitted to Health Canada. In response to this, a group of Canadian clinical dementia experts representing a number of organizations, including the Canadian Geriatrics Society, was convened by the Canadian Consortium on Neurodegeneration in Aging (CCNA) to discuss the evidence currently available on this agent and seek consensus on what advice they would offer Health Canada on the application. There was wide-spread agreement that it would be premature for aducanumab to receive approval for the treatment of Alzheimer’s disease. It was also noted that the Canadian health-care system is poorly prepared at this time to deal with a disease-modifying therapeutic with targeting, administration, and monitoring characteristics like aducanumab. In this paper, the consensus reached is presented along with its underlying rationale. 

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Published

2021-12-01

How to Cite

1.
Chertkow H, Rockwood K, Hogan DB, Phillips N, Montero-Odasso M, Amanullah S, Black S, Bocti C, Borrie M, Feldman H, Freedman M, Hsiung R, Kirk A, Masellis M, Nygaard H, Rajji T, Verret L. Consensus Statement Regarding the Application of Biogen to Health Canada for Approval of Aducanumab. Can Geriatr J [Internet]. 2021 Dec. 1 [cited 2022 May 22];24(4):373-8. Available from: https://cgjonline.ca/index.php/cgj/article/view/570

Issue

Section

Commentaries