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In a significant advancement for Alzheimer’s disease management, Health Canada has granted approval for donanemab, marketed as Kisunla by Eli Lilly, to slow disease progression. This decision, announced on Monday, marks a pivotal moment in the fight against Alzheimer’s, following the earlier approval of lecanemab (Leqembi) in October 2025. The approval comes as a beacon of hope to individuals diagnosed in the early stages of this debilitating condition.
A New Frontier in Alzheimer’s Treatment
Donanemab is the second drug of its kind to receive Health Canada’s endorsement, a testament to the ongoing research and development in the field of neurodegenerative diseases. The U.S. Food and Drug Administration previously approved donanemab in 2024, reflecting a growing recognition of the need for effective treatments that can alter the course of Alzheimer’s.
Both donanemab and lecanemab target amyloid proteins, which accumulate in the brains of Alzheimer’s patients. These proteins form plaques that can disrupt cognitive functions, leading to significant memory and reasoning difficulties. While neither treatment is classified as a cure, they offer the potential to decelerate cognitive decline, providing patients and their families with additional time to navigate the challenges of the disease.
Clinical Trials and Patient Outcomes
Eli Lilly’s clinical trials reveal promising results for Kisunla, particularly for patients in the early stages of Alzheimer’s. According to the company, individuals treated with donanemab exhibited a 22 per cent reduction in disease progression overall, with those less advanced in their condition experiencing a remarkable 35 per cent slowing of decline on the integrated Alzheimer’s Disease Rating Scale (iADRS).
This scale evaluates crucial aspects of daily living, including memory and cognitive function, which are vital for maintaining independence. Notably, many participants in the trials were able to discontinue treatment after their amyloid levels normalised, with some ceasing treatment within just six months.
Voices of Advocacy and Expert Insight
Christina Scicluna, CEO of the Alzheimer Society of Canada, hailed the approval as a “hopeful milestone” for both patients and their caregivers. She emphasised the importance of research and advocacy in facilitating access to such treatments, stating, “While not a cure, it shows how far we’ve come.”
Dr. Sharon Cohen, a neurologist and medical director at the Toronto Memory Program, echoed this sentiment, highlighting the potential for donanemab to help patients maintain their autonomy. “Changing the downward trajectory of Alzheimer’s disease is of the utmost importance,” she remarked, noting the profound impact of Alzheimer’s on patients’ lives.
However, Health Canada has specified that the treatment is not intended for adults with the APOE4 gene variant, which significantly heightens the risk of developing dementia for about one-fifth of the global population.
Next Steps for Accessibility
The approval of donanemab now paves the way for Canada’s Drug Agency to evaluate whether this new treatment will receive funding from provincial and territorial drug plans. The Alzheimer’s Society of Canada is committed to advocating for its inclusion in public drug coverage, although it cautions that this process can take up to two years following regulatory approval.
In the meantime, individuals with private health insurance may find themselves with quicker access to Kisunla, highlighting the disparities that can exist in healthcare access based on insurance coverage.
Why it Matters
The approval of donanemab represents a crucial step forward in Alzheimer’s treatment options, offering renewed hope to those diagnosed with the disease and their families. With the potential to slow cognitive decline significantly, this new therapy not only addresses a pressing medical need but also underscores the importance of continued research and advocacy in the realm of neurological health. As Canada navigates the complex terrain of drug funding and accessibility, the emphasis must remain on ensuring that all patients, regardless of their financial circumstances, can benefit from these groundbreaking advancements in treatment.
