The Food and Drug Administration (FDA) approved a new treatment for Alzheimer's disease, Aduhelm (aducanumab) through their accelerated approval pathway, which the FDA describes as being a pathway "used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments…and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit." This is the first new Alzheimer's disease treatment to be approved since 2003, and the first drug that has been shown to be disease modifying instead of symptom modifying (in research studies, aducanumab has been shown to decrease levels of amyloid plaque in the brains of people with Alzheimer's disease).

Aducanumab has not been shown to improve cognition or halt the disease, but it was shown to slow decline in a limited population of people with Alzheimer’s disease who have  early dementia or mild cognitive impairment (a precursor to dementia). Biogen, the pharmaceutical company that developed the drug and conducted the initial clinical trials, is required to conduct post-approval studies (i.e., phase IV studies) on aducanumab to verify benefit of the drug. If clinical benefit of aducanumab is not verified, it could lead the FDA to remove the drug from the market. The CU Alzheimer's and Cognition Center has been chosen as a site for this clinical trial. 

The Memory Disorders Clinic has also been working to develop processes for including aducanumab as a potential treatment for appropriate patients, and we will provide an update when that information is available. At this time, even though the FDA has approved aducanumab, it is not yet available, because insurance companies, including Medicare, are still determining who will be covered to receive this treatment. We ask that you please be patient while these decisions are made and processes are developed, and if you are interested in seeing if aducanumab is right for you or a family member, please discuss it with your doctor.

The approval of aducanumab is surrounded in some controversy, as the FDA advisory panel did not recommend aducanumab’s approval at their meeting on November 6, 2020. The physicians and scientists at the CUACC will remain up-to-date on the scientific evidence and regulatory issues related to aducanumab. In the meantime, continued research and optimal clinical care for people living with Alzheimer's disease and their families remain our absolute priority.  We are hopeful that aducanumab will be just the first of a new generation of Alzheimer’s disease modifying therapies.

For more information on aducanumab and its approval, please review the press release from Biogen and the press release from the FDA. We also recommend reviewing the University of Michigan Alzheimer's Disease Center's  Frequently Asked Questions page. Please keep in mind some of the answers found on this page may pertain to the processes specific to the University of Michigan. 

9news - Dr. Huntington Potter, director of the CU Alzheimer's and Cognition Center, discusses the Alzheimer's research happening at CU Anschutz, how it is different from the recently FDA approved aducanumab, and what the approval means for future drug development & clinical research.

Denver Channel 7 - Dr. Victoria Pelak discusses the approval of aducanumab and how the CU Alzheimer's and Cognition Center will play a role in the Phase IV clinical trial. 

Newsy/Denver Channel 7 - Dr. Huntington Potter contributes to the discussion around the FDA's approval of aducanumab. 

Links to more information

Biogen press release regarding Aduhelm approval

Eisai press release regarding Leqembi approval

FDA press release for Aduhelm

FDA press release for Leqembi

University of Michigan Frequently Asked Questions

For more information on the advisory panel meeting on November 6, 2021 for aducanumab, check out this New York Times article or this article from Science.

You can find out more about aducanumab here.