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In June 2021, the US Food and Drug Administration (FDA) announced that it had approved aducanumab for the treatment of Alzheimer’s disease.1 The FDA used its accelerated approval process, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a marker of the disease rather than a patient-oriented outcome. In this case, the approval decision was based on levels of amyloid-beta in the brain, an unvalidated surrogate marker. A recent review has called into question evidence linking this surrogate marker to an effect on cognitive function.2 Furthermore, in November 2020, the specialist committee that advised the FDA on this application had noted that while the drug has some effect on amyloid pathology, 10 of its 11 members …
Competing interests None declared. Refer to the online supplementary files to view the ICMJE form(s).
Provenance and peer review Commissioned; externally peer reviewed.
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