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.
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
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. 2021;78(11):1307–1308. doi:10.1001/jamaneurol.2021.3126
Monkeypox Resource Center
Customize your JAMA Network experience by selecting one or more topics from the list below.