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September 13, 2021

US Food and Drug Administration Approval of Aducanumab—Is Amyloid Load a Valid Surrogate End Point for Alzheimer Disease Clinical Trials?

Author Affiliations
  • 1University of Bordeaux, CNRS, IMN, UMR 5293, Bordeaux, France
  • 2Centre Mémoire Ressources Recherches, Pôle de Neurosciences Cliniques, CHU de Bordeaux, Bordeaux, France
  • 3AP-HP Sorbonne Université, Hôpital Pitié-Salpêtrière, Department of Neurology, Institute of Memory and Alzheimer’s Disease, Paris, France
  • 4Institut du Cerveau - ICM, Sorbonne Université, INSERM U1127, CNRS 7225, Paris, France
JAMA Neurol. Published online September 13, 2021. doi:10.1001/jamaneurol.2021.3126

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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