On June 7, 2021, the US Food and Drug Administration (FDA) publicly announced that it would grant accelerated approval for aducanumab in patients with Alzheimer disease (AD) based on the “evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients.”1 To our knowledge, for the first time in the field of AD, a government agency has used a surrogate end point for drug approval, ie, an end point “that is thought to predict clinical benefit but is not itself a measure of clinical benefit.”1 The FDA considered reduction of amyloid load, as measured with amyloid positron emission tomography (PET), to be a valid surrogate end point of clinical benefit in AD. This position is unprecedented and raises numerous controversies.
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Planche V, Villain N. US Food and Drug Administration Approval of Aducanumab—Is Amyloid Load a Valid Surrogate End Point for Alzheimer Disease Clinical Trials? JAMA Neurol. Published online September 13, 2021. doi:10.1001/jamaneurol.2021.3126
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