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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Manly JJ, Glymour MM. What the Aducanumab Approval Reveals About Alzheimer Disease Research. JAMA Neurol. Published online October 04, 2021. doi:10.1001/jamaneurol.2021.3404
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