President’s Message: New Alzheimer’s Drug Approval Slammed by Scientists
I’d like to share an important update on the Alzheimer’s drug, Aducanumab, marketed as Aduhelm in the US.
Aduhelm is a monoclonal antibody drug which means that it mimics our own antibodies to prevent the build-up of beta-amyloid plaque. Researchers still don’t have an answer to whether this drug prevents cognitive decline or slows down Alzheimer’s symptoms. It has been tested among patients with very early stage Alzheimer’s, who have mild symptoms of the disease.
Beyond that, it’s not even clear that amyloid is a cause of Alzheimer’s. It may just be a coincidental finding.
As stated in the recent paper published by the Journal of Alzheimer’s Disease, “Making the Case for Accelerated Withdrawal of Aducanumab,” due to significant concerns for the dementia field and drug approval process, considering its lack of adequate evidence for clinical efficacy, safety issues, and cost, the FDA Peripheral and Central Nervous System Drugs Advisory Committee voted nearly unanimously not to recommend the approval of Aduhelm for the treatment of early AD.
In June 2021, contrary to the recommendation of their own advisory committee and the FDA Office of Biostatistics, the FDA granted Aduhelm Accelerated Approval for marketing. This decision was based on a surrogate marker, i.e., the lowering of amyloid plaque burden on PET scan being “reasonably likely” to predict clinical benefit.
European and Japanese regulators were not convinced and declined to approve Aduhelm.
In December 2021, an international group of clinicians, basic science experts, psychological and social science researchers, lay people who had experience with dementia, and advocates for public health, met to discuss making a recommendation for whether Aduhelm’s approval should be withdrawn. Attendees voted unanimously for the FDA to withdraw its approval for Aduhelm.
This group of esteemed experts believes that more data is needed to confirm if anti-amyloid is the right direction to go in the first place. We await the FDA’s decision.
This is something I think you need to know.
In the meantime, you can rest assured you’re doing everything you can to maximize your brain function by following ARPF’s 4 Pillars of Alzheimer’s Prevention®.
Whitehouse, P., Gandy, S., Saini, V., George, D. R., Larson, E. B., Alexander, G. C., Avorn, J., Brownlee, S., Camp, C., Chertkow, H., Fugh-Berman, A., Howard, R., Kesselheim, A., Langa, K. M., Perry, G., Richard, E., & Schneider, L. (2022, January 1). Making the case for accelerated withdrawal of aducanumab. Journal of Alzheimer’s Disease. Received July 18, 2022, from https://content.iospress.com/articles/journal-of-alzheimers-disease/jad220262