In a significant advancement for Alzheimer’s care, Health Canada has granted approval for Kisunla, a medication designed to decelerate the progression of the disease. Manufactured by Eli Lilly, this new treatment, scientifically known as donanemab, is the second drug of its kind to receive regulatory endorsement in Canada, following lecanemab, or Leqembi, which was approved in October 2025. This news offers a glimmer of hope for individuals battling early-stage Alzheimer’s and their families.
Promising Developments in Alzheimer’s Treatment
The announcement from Health Canada, made public on Monday, highlights a pivotal moment in the ongoing fight against Alzheimer’s disease. Donanemab has already received the green light from the U.S. Food and Drug Administration in 2024, marking a growing recognition of the need for effective treatments in this critical area of healthcare.
Both donanemab and lecanemab operate by targeting amyloid plaques—sticky proteins that accumulate in the brain and are implicated in cognitive decline associated with Alzheimer’s. These plaques are believed to hinder memory and cognitive functions, crucial elements in maintaining independence and quality of life for those affected.
While it’s important to clarify that Kisunla is not a cure, clinical trials have demonstrated its efficacy in slowing cognitive decline in certain individuals. According to the Alzheimer’s Society of Canada, the treatment showed promise in enhancing memory, daily functioning, and overall cognitive performance for many patients in the early stages of the disease.
Clinical Trial Insights
Eli Lilly’s clinical trials reveal encouraging outcomes for patients using Kisunla. Notably, some participants were able to discontinue treatment after their amyloid plaques were cleared, with nearly half ceasing treatment within 12 months. The most substantial benefits were observed in individuals who were less advanced in their illness, with a reported 35 per cent slowing of decline on the integrated Alzheimer’s Disease Rating Scale (iADRS) over 18 months.
The overall data indicates an average of 22 per cent reduction in disease progression across the trial population. These findings resonate deeply with advocates and healthcare professionals who stress the importance of early intervention in Alzheimer’s treatment.
A Broader Context of Care
Christina Scicluna, CEO of the Alzheimer Society of Canada, expressed optimism regarding this development. She described the approval as a “hopeful milestone” for those living with early Alzheimer’s and their caregivers. Scicluna emphasised that while Kisunla does not provide a cure, it highlights significant progress in research and advocacy, reinforcing the need for accessible treatment options and supportive resources for patients.
Dr. Sharon Cohen, a neurologist and medical director at the Toronto Memory Program, further underscored the significance of this breakthrough. She noted that for individuals in the early stages of Alzheimer’s, the ability to maintain independence is paramount. “Changing the downward trajectory of Alzheimer’s disease is of utmost importance,” Dr. Cohen stated. “Individuals at early stages of this disease live in their own homes and lead robust lives but often dread what is to come.”
Limitations and Future Considerations
Despite the enthusiasm surrounding Kisunla, Health Canada has stipulated that the treatment is only to be administered to adults who do not carry the APOE4 gene, a genetic variant that heightens the risk of dementia and is present in approximately 20% of the global population. Additionally, potential side effects include amyloid-related imaging abnormalities (ARIA), which may manifest as temporary swelling in the brain.
The next crucial step involves Canada’s Drug Agency evaluating whether donanemab will be included in provincial and territorial drug plans for reimbursement. The Alzheimer’s Society of Canada has committed to advocating for public coverage of the drug, although they caution that it may take up to two years after regulatory approval for new treatments to be publicly funded.
Why it Matters
The approval of Kisunla marks a transformative moment for Alzheimer’s treatment in Canada, offering renewed hope to patients and their families. It reinforces the critical need for continued investment in research and access to innovative therapies that can potentially enhance quality of life for those facing cognitive decline. As we navigate the complexities of Alzheimer’s care, this development underscores the importance of collaboration among healthcare providers, policymakers, and advocacy groups to ensure that advancements in treatment reach those who need them most.
