Health Canada has approved the drug donanemab, sold under the brand name Kisunla, for patients with early-stage Alzheimer's disease [1].
This approval provides a new therapeutic option for patients and families by targeting the underlying cause of the disease rather than just managing symptoms. The drug represents a shift toward disease-modifying treatments that aim to slow the progression of cognitive decline.
Kisunla is a once-monthly therapy that targets amyloid plaques in the brain [2]. Clinical data suggest the medication can halt the progression of the disease once these plaques are cleared [5]. According to Global News, this is the second disease-modifying Alzheimer's drug approved in Canada [3].
"Health Canada approved Kisunla, a once‑monthly treatment for early Alzheimer’s disease, providing a new option for patients and families," Health Canada said in a press release [4].
The treatment is specifically designed for those in the early stages of the condition. Dr. Michele Miller, a neurologist at Toronto General Hospital, said the approval is a hopeful milestone for Canadians living with Alzheimer's, offering a therapy that actually slows the disease [2].
Eli Lilly Canada Inc. developed the drug. A spokesperson for the company said donanemab is the first and only amyloid plaque-targeting therapy with evidence supporting stopping treatment once amyloid plaques are cleared [1].
Access to the medication comes with a significant financial cost. The price of Kisunla is $47,250 per patient per year [4].
The drug's mechanism focuses on the removal of amyloid beta, a protein that clumps together to form plaques. These plaques are widely considered the primary drivers of the neurodegeneration seen in Alzheimer's patients.
“Donanemab is the first and only amyloid plaque‑targeting therapy with evidence supporting stopping treatment once amyloid plaques are cleared.”
The approval of donanemab signals a transition in dementia care from symptom management to disease modification. While the high annual cost may limit accessibility for some patients, the ability to potentially stop treatment once plaques are cleared distinguishes this therapy from other long-term chronic medications, potentially reducing the long-term burden of care for early-stage patients.
