Aduhelm (aducanumab) Approved by FDA on June 7, 2021
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 the benefit of the drug. If the 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.
Links to more information
Biogen Press Release
FDA Press Release
For more information on the advisory panel meeting on November 6, 2021, check out this New York Times
You can find out more about aducanumab here.