Aducanumab, also known by its brand name Aduhelm, is a drug designed for early Alzheimer's disease that received a lot of global media coverage in 2021 and 2022.
The drug is not available in Canada except in clinical trial settings. In June 2022, drug-maker Biogen announced it was withdrawing its submission from regulatory review by Health Canada. Read the Alzheimer Society of Canada position on this.
On this webpage, for Canadians' reference, you will find some timelines about this drug's development and global media coverage. You will also find some facts about the drug and how it has been used in the past.
Aducanumab: A brief timeline
June 7, 2021: The U.S. Food and Drug Administration (FDA) approves aducanumab (Aduhelm) as a new treatment for Alzheimer’s disease. This makes it the first clinical treatment for Alzheimer’s disease to be brought to market in nearly 20 years.
December 16, 2021: The European Medicines Agency recommends the refusal of the marketing authorisation for aducanumab.
June 9, 2022: Drug-maker Biogen withdraws aducanumab from regulatory review with Health Canada. A Biogen press release states that “aducanumab was submitted [to Health Canada] as a treatment for early stages of Alzheimer’s disease, and based on the review to date, the agency indicated that the data provided would not be sufficient to support a marketing authorization in Canada." Biogen’s statement indicates that the drug is still available through clinical trials.
December 29, 2022: Two U.S. Congressional committees release a staff report and investigation into the FDA's aducanumab approval process. It finds that communications between the FDA and Biogen were "inappropriate" and "atypical."
Key facts about aducanumab
- While approved in the U.S., this drug is not approved in Canada, nor in Europe.
- Aducanumab is not designed for all people at all stages of Alzheimer’s disease. It is designed for people in the early stages of Alzheimer's disease or people with mild cognitive impairment.
- The U.S. FDA has required aducanumab’s manufacturer, Biogen, to complete an additional clinical trial to verify the drug’s benefit. If the trial fails to verify the clinical benefit, the FDA may initiate proceedings to withdraw approval.
Questions Canadians have asked us about aducanumab
Can I go to the U.S. to access aducanumab?
Canadians can travel out of country to seek medical treatment, but in most circumstances, this drug would be an out-of-pocket expense. You would need to check with your provincial or territorial drug plan to find out what costs, if any, may be reimbursed.
How is aducanumab intended to work?
Aducanumab is intended to slow the decline in cognitive skills and functional ability. Its makers propose it does this by clearing amyloid beta that builds up in the brain. Amyloid beta is thought to result in Alzheimer’s disease. However, these effects have only been shown in people living with mild memory or thinking problems.
How is aducanumab taken or administered?
Aducanumab is administered as an intravenous (IV) infusion every four weeks. Patients receiving aducanumab treatment will be required to undergo brain magnetic resonance imaging (MRI) prior to treatment and multiple times following treatments.
What are the reported side effects of aducanumab?
Side effects of aducanumab may include Amyloid Related Imaging Abnormalities (ARIA) (brain swelling and microhemorrhages), superficial siderosis (toxic buildup of protein), swelling of the skin, hives, headache, confusion, delirium, altered mental status, disorientation, falls, dizziness, vertigo, visual disturbance, nausea and diarrhea.
How much does aducanumab cost?
When it was first released onto the U.S. market in June 2021, aducanumab cost about $4,312 USD per infusion or about $56,000 USD annually.
On December 20, 2021, the drug's maker, Biogen, announced it would be reducing the cost of the drug.
As of January 1, 2022, the yearly cost of the drug is slated to be roughly $28,200 USD annually. Exact cost varies depending on the weight of the patient and their dosing level.
What is the Alzheimer Society of Canada’s stance on aducanumab today?
When aducanumab was approved by the U.S. FDA in June 2021, the Alzheimer Society was cautiously hopeful about the approval of a new treatment for Alzheimer’s disease pending full data and results being made publicly available.
After that point, the Alzheimer Society had been waiting on trusted data and review by Canada’s regulatory bodies for further information and assessment.
On June 9, 2022, it became public that Health Canada was not likely to support a marketing authorization for aducanumab in Canada based on current data.
The Alzheimer Society of Canada trusts and supports Health Canada’s regulatory expertise and decision-making in this matter.
As we move ahead, we continue to advocate for more investment and research into dementia cures, as well as into dementia care solutions:
- We know that even if aducanumab had met with Health Canada approval, the fact would remain that aducanumab is not suitable for all people, at all stages of dementia.
- More investment in dementia research is needed to provide people living with dementia and their families new and better treatment and to find a cure for this growing disease.
- The Alzheimer Society remains committed to funding innovative dementia research focused on prevention, diagnosis, treatment, and finding cures for Alzheimer’s disease and other dementias.
What medications are available to help people with Alzheimer’s disease in Canada?
There are currently four medications approved by Health Canada that can help manage symptoms of Alzheimer’s disease.
What other drugs are currently in phase 2 and 3 clinical trials? Are any of them promising?
There are several drugs currently being tested through clinical trials. In total, in 2020, there were 126 agents in 152 trials assessing new therapies for Alzheimer’s disease:
- 28 treatments in Phase 3 trials
- 74 in Phase 2 trials
- 24 in Phase 1 trials
Alzheimer’s disease and other dementias are complex and not yet fully understood, so much of today’s research focuses on several areas of study. Some promising targets for new treatments to slow or stop the progression of the disease have been identified by researchers (for example, neuroinflammation, and the buildup of beta-amyloid and tau in the brain).
It’s believed that future treatments will involve risk reduction strategies and the combination of medications or devices that address several disease targets.
While the number of potential treatment options currently being explored represents a significant improvement over the years, dementia research funding is still far behind any other major disease resulting in fewer drugs in the pipeline of clinical trials. More research is needed to explore better treatments options for all people living with dementia.
For more information
- For more information about whether a particular drug of any kind is right for you, speak to your health-care provider.
- To get free dementia help in your area, contact your local Alzheimer Society using the details at alzheimer.ca/HelpNearYou.
- Get the full picture of how a drug gets approved for public use in Canada, including a list of the currently approved medications that can help manage the symptoms of Alzheimer's disease, by reading our information sheet on the Drug approval process for the treatment of Alzheimer’s disease.
- If you're interested in sharing your thoughts about aducanumab, or have other questions for us, please write to us at [email protected].