Aducanumab (Aduhelm®), which received accelerated approval as a treatment for Alzheimer's disease from the U.S. Food and Drug Administration (FDA) in 2021, will be discontinued by its manufacturer (Biogen) in 2024.
Aducanumab was the first therapy to demonstrate that removing beta-amyloid, one of the hallmarks of Alzheimer's disease, from the brain reduces cognitive and functional decline in people living with early Alzheimer's.
Aducanumab's approval was a landmark event for the Alzheimer's field, and there continue to be many advancements in treatment.
Learn more about other available FDA-approved treatments: Medications for Memory, Cognition and Dementia-Related Behaviors
For more information about aducanumab, see below. Contact the Alzheimer's Association 24/7 Helpline at 800.272.3900 with questions.
Why is Biogen discontinuing aducanumab?
According to Biogen, aducanumab will be discontinued in order for the company "to reprioritize its resources in Alzheimer's disease." Aducanumab is not being discontinued for reasons related to safety or efficacy.
What should someone know and consider if taking this treatment?
Biogen stated that people who are now receiving the drug as part of a clinical trial will continue to have access to it until May 1, 2024, and that people who are now receiving it by prescription will have it available to them until Nov. 1, 2024.
The Alzheimer's Association recommends that people receiving aducanumab, and their families, should connect with their study contact and/or their health care provider to talk through how these changes will impact their treatment and care.
Is aducanumab a cure for Alzheimer's and all other dementia?
No. Aducanumab addresses the underlying biology of the disease. According to the FDA, aducanumab reduces beta-amyloid plaques, which is reasonably likely to lead to a reduction in clinical decline due to Alzheimer's disease.
This could mean more time for individuals to actively participate in daily life, have sustained independence and hold on to memories longer.
What is mild cognitive impairment?
Mild cognitive impairment (MCI) is an early stage of memory loss or other cognitive ability loss in individuals who maintain the ability to independently perform most activities of daily living.
Who should take this drug?
Aducanumab is indicated for the treatment of Alzheimer's disease. The drug was studied in people living with early Alzheimer's disease — which includes people with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease who also have evidence of a buildup of amyloid plaques in the brain. Treatment with aducanumab may be appropriate for people in the disease stage studied in the clinical trials. There is no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
How does aducanumab work?
Aducanumab is designed to target and remove specific forms of beta-amyloid that accumulate into plaques, which may contribute to cell death and tissue loss in areas of the brain particularly important for memory, thinking, learning and behaviors. The brain goes on creating beta-amyloid, but aducanumab decreases the amount. Its removal may also help other processes in your brain to operate more efficiently.
How to navigate treatment options
There is exciting progress in Alzheimer’s and dementia research that is creating promising new treatments. It is important to learn as much as you can about which drugs are available.
Will this drug restore memories or cognitive function that has been lost?
There is no evidence that aducanumab can restore lost memories or cognitive function.
What type of diagnostic test is the FDA requiring?
The FDA is not requiring any specific diagnostic test. However, the label says aducanumab is indicated for the treatment of Alzheimer's, based on reduction in beta-amyloid plaques, one of the hallmarks of the disease. This means that a physician should confirm the presence of beta-amyloid plaques in the brain before prescribing this anti-amyloid plaque treatment.
Confirmatory tests like cerebrospinal fluid analysis or amyloid PET imaging should be a part of the diagnostic process to determine eligibility for the treatment.
How is this drug administered?
Aducanumab is administered intravenously (IV) via a 45- to 60-minute infusion every 4 weeks. Infusion can be done at hospitals or infusion therapy centers. Aducanumab needs to be given by IV in order for the medication to reach the brain most effectively.
Communicate with your health care team
Effective communication with care team members — particularly health care providers — is critical to ensure that the person living with dementia receives the best possible care.
How does aducanumab compare to other monoclonal antibodies?
While monoclonal antibodies like aducanumab, lecanemab and donanemab (currently unapproved by the FDA) that target beta-amyloid in the brain belong to the same class of treatments, no treatments are the same. They work differently by targeting beta-amyloid at different stages of plaque formation, and ultimately these treatments lower beta-amyloid to slow progression of the disease and to reduce clinical decline.