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Health Canada has approved a second drug that can slow the progression of Alzheimer’s disease.
Donanemab, sold by American drugmaker Eli Lilly under the brand name Kisunla, received Health Canada approval on Monday, the company said in a press release.
It received approval from the U.S. Food and Drug Administration in 2024.
This is the second disease-slowing drug for Alzheimer’s that has been approved in Canada, after Health Canada approved lecanemab, commercially known as “Leqembi,” in October 2025.
Donanemab, like lecanamab, targets amyloids — a sticky protein that develops in the brain in the early stages of Alzheimer’s disease. The buildup of amyloid plaques in the brain may lead to memory and thinking issues.
While the drug is “not a cure,” clinical trials indicated the potential to slow decline in memory, thinking and daily functioning for some people in the early stages of Alzheimer’s disease, the Alzheimer’s Society of Canada said.
In clinical trials, patients taking Kisunla were able to stop treatment once amyloid plaques were cleared, with some stopping after just six months and nearly half discontinuing treatment after 12 months, Eli Lilly said in a statement.
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Patients in the early stages of the disease saw the greatest benefits of the drug, the company added.
Over 18 months, participants who were less advanced in their disease showed a 35 per cent slowing of decline on the integrated Alzheimer’s Disease Rating Scale (iADRS), which assesses memory, thinking and daily functioning, the company said.
For the overall population, donanemab showed a 22 per cent slowing of the disease, the statement added.
The approval is “a hopeful milestone for people living with early Alzheimer’s and their care partners,” Alzheimer Society of Canada CEO Christina Scicluna said.
“While not a cure, it shows how far we’ve come and why research and advocacy matters. Together with our partners across Canada, we remain focused on ensuring people can access new treatments alongside the practical supports they need to navigate what comes next,” Scicluna added in a statement.
The drug “provides an important opportunity for early patients to maintain their independence,” said Dr. Sharon Cohen, neurologist and medical director at the Toronto Memory Program.
“Changing the downward trajectory of Alzheimer’s disease is of the utmost importance. Individuals at early stages of this disease live in their own homes and lead robust lives but often dread what is to come.”
Health Canada has limited the use of the treatment for adults who don’t carry the APOE4 gene.
This genetic variant, carried by one-fifth of the world’s population, significantly increases the risk of dementia.
Side effects of the therapy may include amyloid-related imaging abnormalities (ARIA). This “may present as temporary swelling in an area or areas of the brain,” Eli Lilly said.
Canada’s Drug Agency will now assess whether donanemab should be funded by provincial and territorial drug plans. The Alzheimer’s Society of Canada said it will advocate for the drug to be covered by public drug plans, but cautioned that it can take up to two years after regulatory approval for new medicines to become publicly covered.
People with private insurance or extended health benefits often gain access to treatments more quickly, the society added.
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