On June 9, 2022, Biogen announced it will withdraw its submission of aducanumab from regulatory review by Health Canada as a treatment for people living with early stages of Alzheimer’s disease. Read the Alzheimer Society of Canada position on this statement.
On June 7, 2021, the U.S. Food and Drug Administration (FDA) approved aducanumab (Aduhelm) as a new treatment for Alzheimer’s disease. This was potentially exciting news for the more than half a million people in Canada living with Alzheimer’s disease and other dementias, as no other clinical treatment intended for Alzheimer’s disease had been brought to market in nearly 20 years.
While that approval was notable, it has not been universal. On December 16, 2021, the European Medicines Agency recommended the refusal of the marketing authorisation for aducanumab.
On June 9, 2022, drug-maker Biogen withdrew aducanumab from regulatory review with Health Canada.
A Biogen press release on June 9, 2022 stated 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.
Here are some important things for Canadians to know about aducanumab:
- While approved in the U.S., the drug is not approved in Canada.
- Aducanumab is not suitable for all people at all stages of Alzheimer’s (see Who can take aducanumab?, below).
- The U.S. FDA requires 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.
- If you are unsure whether aducanumab will be suitable for you, the Alzheimer Society strongly recommends talking to your doctor or an appropriate healthcare provider (see Who can take aducanumab?, below).
Is aducanumab available in Canada?
Aducanumab is available in Canada in the context of ongoing clinical trials only.
In fall 2021, Health Canada began its regulatory review of aducanumab – a compulsory step for any drug being made available in Canadian markets.
On June 9, 2022, drug-maker Biogen withdrew aducanumab from review with Health Canada. This decision followed an indication from Health Canada that Biogen’s data was not sufficient to support marketing authorization.
Also in fall 2021, optional value-focused reviews by the Canadian Agency for Drugs and Technology in Health and Institut national d’excellence en santé et en services sociaux began.
The review by the Canadian Agency for Drugs and Technology in Health was suspended at Biogen’s request in winter 2021.
What data, if any, has the Alzheimer Society of Canada collected about aducanumab?
In fall 2021, the Alzheimer Society of Canada created a survey for people living with Alzheimer's disease or mild cognitive impairment. That survey aimed to amplify the voices of people with lived experience of dementia in the value-focused drug-review process of aducanumab.
That survey has now closed, but any public results will be posted here in the months to come.
Are there any clinical trial sites in Canada where I can access aducanumab?
The Alzheimer Society of Canada is not aware of any current Canadian clinical trials for aducanumab with open recruitment at this time. We will update this page as we become aware of aducanumab trials in Canada.
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. Check with your provincial drug plan to find out what costs may be reimbursed.
Who can take aducanumab?
Aducanumab is not suitable for all people at all stages of dementia. The FDA in the U.S. recommends that the drug should only be used by people living with mild cognitive impairment (MCI) or in the early stages of Alzheimer’s disease.
How is aducanumab intended to work?
Aducanumab is reported to slow the decline in cognitive skills and functional ability. It does this by clearing amyloid beta that builds up in the brain, which is thought to result in Alzheimer’s disease. However, these effects have only been shown in people living with mild memory or thinking problems.
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.
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.
Costs are another factor to be aware of. 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’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 other medications are available to treat Alzheimer’s disease?
There are currently four medications, approved by Health Canada, that can treat symptoms of Alzheimer’s. These medications may slow the rate of cognitive decline, or help with symptoms such as changes in language, thinking abilities and movement.
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, and
- 24 in Phase 1.
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.
Looking for more information?
- If you are interested in taking aducanumab, the Alzheimer Society strongly recommends talking to your doctor about it and whether it will be suitable for you.
- You can also contact your local Alzheimer Society for further information and support. Visit 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 treat the symptoms of Alzheimer's, by reading our information sheet on the Drug approval process for the treatment of Alzheimer’s disease.
- The Alzheimer Society encourages Canadians to listen to the perspectives of people living with dementia regarding aducanumab:
- For example, an episode of CBC's The Current from June 2021 (listen here) features Bob Murray, a resident of Seaforth, Ontario and a member of our Advisory Group of People with Lived Experience of Dementia. (The conversation about aducanumab begins at 22:54, and the interview with Bob begins at 31:00.)
- If you're interested in sharing your thoughts about aducanumab, please write to us at firstname.lastname@example.org.