On November 6, 2020, a US Food and Drug Administration (FDA) advisory committee reviewed issues related to the efficacy and safety of aducanumab, a human IgG1 anti-Aβ monoclonal antibody specific for β-amyloid oligomers and fibrils implicated in the pathogenesis of Alzheimer disease.1 Given the importance of drug innovation for this common and often devastating disease, the abandonment of prior monoclonal antibodies targeting β-amyloid, and the clinical, regulatory, and market effects that approval of aducanumab could have, there has been significant interest in the development and regulatory review of aducanumab.
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.
Alexander GC, Emerson S, Kesselheim AS. Evaluation of Aducanumab for Alzheimer Disease: Scientific Evidence and Regulatory Review Involving Efficacy, Safety, and Futility. JAMA. 2021;325(17):1717–1718. doi:10.1001/jama.2021.3854
Coronavirus Resource Center
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: