Health Canada approves new Alzheimer’s therapy

Published 1:00 pm Thursday, June 4, 2026

Clinical trials have shown donanemab can slow declines in memory, thinking and daily functioning among people with mild cognitive impairment or mild dementia caused by Alzheimer’s disease. (Unsplash)

Health Canada has approved donanemab, a new disease-modifying treatment for people with mild cognitive impairment or early-stage Alzheimer’s disease.

Announced May 1, the approval makes donanemab the second treatment authorized in Canada that targets the underlying biology of Alzheimer’s disease rather than only managing symptoms.

The decision follows Health Canada’s recent conditional approval of lecanemab, the first new Alzheimer’s treatment approved in Canada in more than a decade.

Both therapies are administered through intravenous infusions and work by targeting amyloid plaques in the brain, allowing the body’s immune system to remove them.

Unlike lecanemab, however, treatment with donanemab can be discontinued once amyloid levels fall below a specified threshold.

Health Canada has restricted eligibility to people with one or no copies of the APOE4 gene. Research indicates individuals with two copies face a significantly higher risk of brain swelling and small brain bleeds while taking the medication.

The restriction mirrors guidelines already in place for lecanemab and in other countries.

The decision means more patients will require genetic testing to determine eligibility, along with regular MRI scans to monitor for potential side effects. Additional testing is also needed to confirm the presence of amyloid plaques before treatment can begin.

Although approved, donanemab is not yet publicly available.

Information about accessing new medicines in Canada is available on the Innovative Medicines Canada website at innovativemedicines.ca.