Aducanumab is the only disease-modifying medication currently approved to treat Alzheimer's. This medication is a human antibody, or immunotherapy, that targets the protein beta-amyloid and helps to reduce amyloid plaques, which are brain lesions associated with Alzheimer's.


Aducanumab, sold under the brand name Aduhelm, is a medication designed to treat Alzheimer's disease. It is an amyloid beta-directed monoclonal antibody that targets aggregated forms of amyloid beta found in the brains of people with Alzheimer's disease to reduce its buildup. It was developed by Biogen and Eisai.


The controversial approval in June 2021 by the Food and Drug Administration (FDA) of aducanumab (marketed as Aduhelm), Biogen's monoclonal antibody for patients with Alzheimer's disease, raises significant concerns for the dementia field and drug approval process, considering its lack of adequate evidence for clinical efficacy, safety issues, and cost. On 15 December 2021, an international group of clinicians, basic science experts, psychological and social science researchers, lay people with lived experience of dementia, and advocates for public health met to discuss making a recommendation for whether aducanumab's approval should be withdrawn. Attendees considered arguments both in favor of and in opposition to withdrawal and voted unanimously to recommend that the FDA withdraw its approval for aducanumab and to support the Right Care Alliance's filing of a formal Citizen Petition to this effect 1).


1)
Whitehouse P, Gandy S, Saini V, George DR, Larson EB, Alexander GC, Avorn J, Brownlee S, Camp C, Chertkow H, Fugh-Berman A, Howard R, Kesselheim A, Langa KM, Perry G, Richard E, Schneider L. Making the Case for Accelerated Withdrawal of Aducanumab. J Alzheimers Dis. 2022;87(3):1003-1007. doi: 10.3233/JAD-220262. PMID: 35404287.
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