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July 13, 2021

Approval of Aducanumab for Alzheimer Disease—the FDA’s Perspective

Author Affiliations
  • 1US Food and Drug Administration, Silver Spring, Maryland
JAMA Intern Med. Published online July 13, 2021. doi:10.1001/jamainternmed.2021.4607

On June 7, 2021, the US Food and Drug Administration (FDA) approved aducanumab (Aduhelm; Biogen Inc), the first new drug for the treatment of Alzheimer disease in 2 decades. Alzheimer disease, the sixth leading cause of death in the US, is a neurodegenerative disease leading to a progressive, irreversible destruction of neurons resulting in loss of cognitive function and memory. Over time, patients develop severe dementia, loss of independence, and death.1 Unfortunately, pharmacologic treatment options have been extremely limited, with the few previously approved drugs providing only symptomatic improvement, but not modifying disease progression. Undoubtedly, there is a substantial unmet medical need in patients with Alzheimer disease. In this Viewpoint, we discuss the complexities of the data supporting the aducanumab application and the rationale for the FDA’s decision to grant it accelerated approval.

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    2 Comments for this article
    Denis POUCHAIN, MD-PHD | Tours University France
    Beyond the p-values on the primary and the secondary "clinical" endpoints, are the differences between groups better than the minimal clinically important difference, and clinically relevant ? I am not sure.
    Comment on the FDA Perspective
    Robert Wang, Ph.D., M.D. | Private Practice

    The studies have shown there is no meaningful signal for clinical benefit with aducanumab. Instead, the signal is for amyloid removal. Yet the studies for aducanumab and for prior synthetic amyloid removing antibodies have demonstrated no significant clinical benefit with a sizeable group of recipients developing mild to severe ARIA leading to accelerated functional decline.

    So the justification really should read that bypassing this opportunity might miss minimal improvement for a small proportion of patients at the cost of significant complications for a different group, although data are lacking to even prove that minimal