In a significant advancement for Alzheimer’s treatment, Health Canada has granted approval for Donanemab, marketed as Kisunla by the American pharmaceutical company Eli Lilly. This decision, announced on Monday, marks a pivotal moment for those affected by this debilitating disease, as it is the second drug of its kind to receive endorsement in Canada, following the approval of Lecanemab (brand name Leqembi) in October 2025.
A New Hope in Alzheimer’s Treatment
Donanemab targets amyloid plaques—sticky proteins that accumulate in the brains of individuals in the early stages of Alzheimer’s, contributing to cognitive decline. While it does not offer a cure, clinical trials suggest that this therapy can slow the progression of memory loss and other cognitive functions for patients diagnosed early in the disease’s course. The Alzheimer Society of Canada noted that this drug could provide a much-needed lifeline for families grappling with the challenges of early-stage Alzheimer’s.
Eli Lilly reported that participants in clinical trials who received Kisunla experienced significant benefits, with some patients able to cease treatment after their amyloid levels normalised. In fact, nearly half of the trial participants stopped treatment after a year, underscoring the potential effectiveness of this therapy.
Clinical Trial Insights
The results from clinical trials reveal a promising picture. Patients in the initial stages of Alzheimer’s exhibited a remarkable 35 per cent reduction in cognitive decline on the integrated Alzheimer’s Disease Rating Scale (iADRS), which evaluates memory, thinking, and daily functioning over an 18-month period. For the broader group of participants, the overall slowing of decline was recorded at 22 per cent.
Christina Scicluna, CEO of the Alzheimer Society of Canada, expressed optimism over the approval, declaring it a hopeful milestone for those living with early Alzheimer’s and their caregivers. She emphasised the importance of ongoing research and advocacy in making treatments accessible to those who need them most.
Safety Considerations and Restrictions
Despite the enthusiasm surrounding Donanemab, Health Canada has imposed restrictions on its usage. The treatment is not available to individuals who possess the APOE4 gene variant, which heightens the risk of developing dementia and is present in roughly 20 per cent of the global population. Potential side effects of the drug may include amyloid-related imaging abnormalities (ARIA), which could manifest as temporary swelling in certain areas of the brain.
The next step for Donanemab involves an assessment by Canada’s Drug Agency to determine whether it will be included in the funding provisions for provincial and territorial drug plans. The Alzheimer Society of Canada has committed to advocating for public coverage of this new treatment, although they caution that it may take up to two years for newly approved drugs to become publicly funded. Meanwhile, individuals with private insurance or extended health benefits may have quicker access to this promising therapy.
Why it Matters
The approval of Donanemab represents a beacon of hope for Canadians facing the challenges of Alzheimer’s disease, particularly in its early stages. As the healthcare community rallies to provide access to innovative treatments, it is crucial that these advancements translate into tangible support for patients and their families. The ongoing dialogue about funding, accessibility, and the importance of research will shape the future landscape of Alzheimer’s care in Canada, ensuring that individuals can maintain their independence and quality of life for as long as possible.
