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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Dunn B, Stein P, Cavazzoni P. Approval of Aducanumab for Alzheimer Disease—the FDA’s Perspective. JAMA Intern Med. Published online July 13, 2021. doi:10.1001/jamainternmed.2021.4607
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