It's been over two years since one of the worst product launches of all time - Aduhelm (aducanumab). Praised by the FDA, Alzheimer’s Association (AA), and Pharma as a “game changer”, but derided by others for the drug’s lack of clinical efficacy, risk of severe adverse effects, absence of diversity in trial populations, high costs, and an FDA approval process that was in the kindest words “rife with irregularities”. Instead of Biogen’s expected billions of dollars of revenue from Aduhelm, they brought in only $3 million in revenue for all of 2021 (here is my Twitter summary of this fiasco).

The outlook on amyloid antibodies are looking brighter though in 2023. Phase III studies for lecanemab and donanemab have been published showing less worsening of cognition and function receiving these agents versus placebo. This led the FDA to give full approval for lecanemab, which will likely be followed by full approval of donanemab sometime this year. However, as noted in our editorial published with the donanemab trial, the modest benefits of amyloid antibodies would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low risk, inexpensive, and simple to administer. However, they are none of these.

So what is the role of individuals like geriatricians in prescribing amyloid antibodies and caring for individuals who are receiving them? We invited three geriatricians and memory care doctors, Nate Chin, Sharon Brangman, and Jason Karlawish, to talk about this question and many others swirling around on how to safely prescribe these drugs and manage patients on them (like what to do about anticoagulation).

Lastly, we also spend a little bit of time talking about the NIA-AA draft statement on redefining Alzhiemers disease. There is a lot to digest with these draft clinical guidelines but the big change from the 2018 guideline is moving Alzheimers to a biological diagnosis (biomarker evidence only) not just for a research framework but now from a clinical one. One outcome would be a very large population of older adults with normal cognition could now be classified as having Alzheimer's disease (maybe about a 1/3 of cognitively normal 75 year olds based on PET). So if you have thoughts on the matter, please give your feedback here to the NIA and AA. https://aaic.alz.org/nia-aa.asp

By: Eric Widera

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