In a significant development for Alzheimer’s treatment in Canada, Health Canada has approved donanemab, branded as Kisunla, a drug that aims to slow the progression of the disease. This announcement was made by American pharmaceutical firm Eli Lilly, marking a pivotal moment for patients and their families navigating the challenges of early-stage Alzheimer’s. The approval follows the drug’s endorsement by the U.S. Food and Drug Administration in 2024 and comes after the earlier approval of lecanemab, known commercially as Leqembi, in October 2025.
Targeting Alzheimer’s Disease
Both donanemab and lecanemab function by targeting amyloid proteins that accumulate in the brain during the early stages of Alzheimer’s disease. The presence of these amyloid plaques is directly linked to cognitive decline, manifesting in memory loss and difficulties with daily tasks.
While donanemab is not a cure for Alzheimer’s, clinical trials demonstrate its potential to decelerate cognitive deterioration in some early-stage patients. According to the Alzheimer Society of Canada, this drug could be transformational for individuals facing the early stages of the disease, allowing them to maintain a higher quality of life for a longer period.
Promising Clinical Trial Results
Clinical trials highlighted the efficacy of Kisunla, revealing that patients could cease treatment once amyloid levels were effectively reduced. Remarkably, some individuals stopped treatment within six months, and almost half of the trial participants discontinued after 12 months. The findings indicate that those at the beginning stages of Alzheimer’s experienced the most pronounced benefits.
In particular, trial participants demonstrated a 35 per cent reduction in cognitive decline over 18 months when measured by the integrated Alzheimer’s Disease Rating Scale (iADRS), which evaluates memory, thinking abilities, and daily functioning. For the broader patient population, the drug exhibited a 22 per cent slowing of the disease’s progression.
Advocacy and Access to Treatment
The CEO of the Alzheimer Society of Canada, Christina Scicluna, expressed optimism regarding the approval, calling it “a hopeful milestone” for those living with early Alzheimer’s and their caregivers. She emphasised the need for ongoing research and advocacy to ensure access to new treatments and necessary support systems.
Dr. Sharon Cohen, a neurologist and medical director at the Toronto Memory Program, echoed these sentiments, stressing the critical nature of altering the trajectory of Alzheimer’s for early-stage patients. Many individuals at this stage continue to lead active lives but often face an uncertain future.
Health Canada has placed restrictions on donanemab’s use, permitting it only for adults who do not carry the APOE4 gene, a variant that increases the risk of dementia for approximately 20 per cent of the population. Additionally, potential side effects include amyloid-related imaging abnormalities (ARIA), which may cause temporary brain swelling.
Looking Ahead: Funding and Accessibility
Following this regulatory approval, Canada’s Drug Agency will evaluate whether donanemab should be included in provincial and territorial drug coverage plans. The Alzheimer Society of Canada has committed to advocating for its inclusion in public drug programmes, although they note that it may take up to two years from regulatory approval for new treatments to be publicly funded. Those with private insurance may access the drug more swiftly, giving them an advantage in treatment options.
Why it Matters
The approval of donanemab represents a significant advancement in the fight against Alzheimer’s disease, offering new hope to patients and families grappling with this challenging condition. As research continues to evolve, the potential for innovative treatments expands, underscoring the importance of advocacy and support in ensuring that these breakthroughs are accessible to all who need them. By prioritising the needs of those living with Alzheimer’s, we can foster a more supportive environment that champions both medical progress and the human experience of those affected.