Health Canada Approves Donanemab
The Alzheimer Society of Canada responds to Health Canada's decision to approve Alzheimer's disease medication donanemab. Find information here about how this treatment works for people with mild cognitive impairment or early-stage Alzheimer’s disease.
On May 1, 2026, Health Canada approved donanemab (Kisunla™) to treat people with a clinical diagnosis of mild cognitive impairment or early-stage Alzheimer's disease (mild dementia due to Alzheimer's disease). This is the second disease-modifying Alzheimer's treatment approved for use in Canada.
The Alzheimer Society of Canada supports Health Canada's decision to authorize donanemab as a treatment for people diagnosed with mild cognitive impairment or early-stage Alzheimer's disease. We respect the careful and thorough process used by Health Canada to assess the safety, efficacy and tolerability data for donanemab.
It’s important to understand that this drug is not a cure.
Despite this approval, donanemab could still take over a year to become accessible through private drug plans and more than two years through public plans. This underscores the critical importance of receiving a timely diagnosis, as the medication is effective only for those in the earliest stages of the disease.
According to the World Alzheimer Report 2024 by Alzheimer's Disease International, over 90 per cent of respondents said they would pursue a dementia diagnosis if they knew a disease-modifying treatment was available. It is the hope of the Alzheimer Society of Canada that as treatments become available, people will be encouraged to seek a diagnosis of dementia earlier.
The Alzheimer Society of Canada continues to advocate for increased research funding for dementia to develop, test, and approve new treatment breakthroughs in the future. We also urge for broader and more equitable access to dementia risk reduction resources, diagnosis tools, symptom management, and care support. This ensures that all people living with dementia, and their care partners, can maintain a good quality of life and access appropriate interventions in a timely manner.
Frequently asked questions
- What is donanemab?
-
- Donanemab is an intravenous monoclonal antibody treatment that removes amyloid plaques (a protein often connected to Alzheimer’s disease) from the brain.
- This drug is not a cure.
- Who is donanemab intended for?
-
- The drug is only approved to be used in people with mild cognitive impairment or mild (early-stage) Alzheimer’s disease.
- This drug is also not supposed to be used for any other form of dementia–only for dementia related to Alzheimer’s disease.
- How much does donanemab cost? Will the cost be covered by provincial/territorial health plans?
-
- Health Canada allows the medication to be marketed and sold within the guidelines set out by Health Canada and the manufacturer.
- It is still unclear how much donanemab will cost in Canada. Donanemab is approved for clinical use in Canada, however whether the cost of the drug is covered by private or public health plans will depend on the province or territory you live in. After a drug is approved by Health Canada, it takes time to determine if or whether the drug will be covered by private and/or public drug plans.
- How can I request donanemab ?
-
- A timely diagnosis of dementia offers many benefits, including better access to treatment options and support, ability to plan for the future, and more meaningful time with family and friends. Learn more about getting a diagnosis.
- Ask your health-care provider if this drug is right for you, and for more information about donanemab assessment and testing procedures. Health-care providers can provide an accurate assessment of your symptoms to determine if you can be treated with donanemab.
- How can I, or someone I know, participate in dementia drug trials and research studies in Canada?
-
- You can find information about clinical trials internationally at clinicaltrials.gov. Some of these trials will have Canadian sites.
- You can also find many Canadian dementia studies, and some clinical trials, to participate in at alzheimer.ca/find-studies.
- What else should I know about the field of dementia drug development right now?
-
- There are many dementia drugs in development internationally. A major push in the drug development field is to find drugs that treat underlying causes of dementia, not just dementia symptoms.
- You can read about medications that are approved to treat dementia in Canada
Help is available
If you have any questions about dementia drugs and access to them, ask your health-care provider if this medication is right for you.
Contact your local Alzheimer Society for more information about programs, resources and support services in your area.
Including living/lived experience of dementia in donanemab reviews
During May-July 2024, the Alzheimer Society of Canada developed an online survey to gather the experiences of people living with Alzheimer's disease or mild cognitive impairment (MCI) due to Alzheimer's disease, and their caregivers, and those who were involved in clinical trials of Leqembi (lecanemab) and/or donanemab. The results of this survey (see links below), were submitted to Health Canada to ensure that the voices of people with living/lived experience are represented and considered during the review process.
More information and resources
Use of new medications for Alzheimer's disease in the Canadian healthcare system by the Canadian Consortium on Neurodegeneration in Aging (CCNA). Frequently asked questions (and answers) about new medications for Alzheimer's disease that may be made available in Canada in the future.
Last updated: May 4, 2026