Update on FDA Approval of Aducanumab

Last Updated January 12, 2022

Our team at the UW Memory and Brain Wellness Center was excited to learn about the FDA’s approval of aducanumab (brand name Aduhelm) for use in certain individuals with Alzheimer’s disease, and would like to share some information about this newest therapy with our patients and community.

• Aducanumab works by removing the amyloid plaques that build up in the brain in Alzheimer’s disease. Through this mechanism, it can slow, to some extent, the progression of the disease.  


• Aducanumab is given intravenously on a monthly basis. Due to potential side effects, a person taking this drug has to have ongoing monitoring.


• The medication is not for everyone. It has only been shown to be effective in those with the mildest symptoms of Alzheimer’s. There is debate about the quality of the evidence and the size of the benefit.  Your medical provider at the Memory and Brain Wellness Center will help determine if you would be a candidate for this medication. Most patients will need additional tests in order to make this determination.


• The Memory and Brain Wellness Center is in the process of implementing the system resources necessary to administer and monitor this medication. For updated information about aducanumab and to keep abreast of when this therapy will be available at the Memory and Brain Wellness Center, please visit this page: depts.washington.edu/mbwc/resources/aducanumab

 

Resources

Webinar recording: Alzheimer’s Association Webinar: Dialogue: Current Perspectives on Aducanumab (June 21, 2021)

About: A special public scientific discussion to provide a balanced collegial dialog to understand the science behind aducanumab, discuss publicly available data surrounding the complexity of the clinical trial results, discuss what we know about the diagnostic biomarkers being used, and the FDA label which dictates which populations this drug will benefit based on the evidence reviewed.

Recording (Recorded on June 21, 2021) NACC and the UW have not received any financial support for the Alzheimer’s Association webinar or Aducanumab.

 

 

Links to information about this decision

• Medicare proposes covering expensive Alzheimer's drug for those in clinical trials - NPR (January 11, 2022)


• CMS Proposes Medicare Coverage Policy for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease Centers for Medicare & Medicaid Services press release)


• Public Comment Form on recent CMS proposed national coverage analysis decision "Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease"- View Public Comments (Centers for Medicare & Medicaid Services)


• Medicare Proposes to Sharply Limit Coverage of the Alzheimer’s Drug Aduhelm - New York Times (January 11, 2022)


• F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug - New York Times (July 8)


• The FDA Announcement: FDA’s Decision to Approve New Treatment for Alzheimer’s Disease by Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research


• National Institute on Aging (NIA) statement: FDA approval of aducanumab for Alzheimer’s disease


• New York Times coverage: FDA Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works


• Times coverage The First Treatment for Alzheimer’s Disease Is Here


• STAT News coverage FDA grants historic approval to Alzheimer’s drug designed to slow cognitive decline  /  A landmark Alzheimer’s drug approval would likely deepen racial inequities in dementia care

 

Local Coverage and Reactions

• YakTriNews.com Local reaction to new controversial FDA-approved Alzheimer’s drug

• The Alzheimer's Association: It’s a New Day in the Fight Against Alzheimer’s — Aducanumab Approved

• Seattle Times Opinion,  June 16, 2021:  The benefits and risks of the new Alzheimer’s drug by Thomas J. Grabowski and Charles Bernick