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October 4, 2021

What the Aducanumab Approval Reveals About Alzheimer Disease Research

Author Affiliations
  • 1Taub Institute for Research on Alzheimer’s Disease and the Aging Brain, Department of Neurology, Columbia University Irving Medical Center, New York, New York
  • 2Department of Epidemiology and Biostatistics, University of California, San Francisco
JAMA Neurol. 2021;78(11):1305-1306. doi:10.1001/jamaneurol.2021.3404

The US Food and Drug Administration (FDA) recently provided accelerated approval for aducanumab to treat Alzheimer disease (AD). The decision was controversial within and outside the FDA because of inadequate evidence of medication efficacy. The Peripheral and Central Nervous System Drugs Advisory Committee voted against recommendation of aducanumab and several committee members resigned after approval. FDA approval was based on trials that were not inclusive of the people who bear a disproportionate burden of disease.1 Only 0.6% (ie, 19 individuals) of participants identified as Black, 3% as Hispanic, 0.03% (1 person) as American Indian or Alaska Native, and 0.03% as Native Hawaiian or Pacific Islander. Of the 9% identified as Asian, 94% were recruited in Asia.2 Older Black adults are estimated to have AD incidence up to double the rates in older White people. Despite this, Biogen reported that only 6 Black people were randomized to the treatment dose approved by the FDA.

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1 Comment for this article
Early Diagnosis
Paul Nelson, MS, MD | Family Health Care, PC retired
Not to mention, that there is no early screening test that exists to accurately predict the eventual occurrence of advanced Senile Dementia. However, Parkinson's Law accurately predicts the cost of this therapy.