In a significant advancement for Alzheimer’s care, Health Canada has granted approval for Donanemab, marketed as Kisunla by Eli Lilly, as a new treatment option aimed at slowing the progression of Alzheimer’s disease. This decision, announced on Monday, follows the drug’s endorsement by the U.S. Food and Drug Administration in 2024, marking a pivotal moment for patients and caregivers grappling with this challenging condition.
Understanding Donanemab and Its Mechanism
Donanemab joins the ranks as the second drug approved in Canada that aims to decelerate the effects of Alzheimer’s, following the approval of lecanemab, known as “Leqembi,” in October 2025. Both medications target amyloid proteins, which accumulate in the brain during the early stages of Alzheimer’s, leading to cognitive decline and memory issues.
While neither treatment is a cure, early studies indicate that Donanemab has the potential to slow cognitive deterioration in patients diagnosed with the early stages of the disease. According to the Alzheimer Society of Canada, clinical trials have demonstrated promising outcomes, with the most significant benefits observed in patients at the initial phases of Alzheimer’s.
Clinical Trial Outcomes
Eli Lilly reported that participants who received Kisunla were able to cease treatment once amyloid plaques were effectively eliminated, with some patients stopping after just six months and nearly half discontinuing after a year. Notably, individuals in the early stages of Alzheimer’s showed a 35 per cent reduction in the rate of decline on the integrated Alzheimer’s Disease Rating Scale (iADRS), which evaluates memory, cognition, and daily functioning. For the broader participant group, the drug resulted in a 22 per cent overall slowing of the disease’s progression.
Christina Scicluna, CEO of the Alzheimer Society of Canada, expressed optimism regarding the drug’s approval, describing it as “a hopeful milestone for people living with early Alzheimer’s and their care partners.”
Expert Insights on the Treatment
Dr. Sharon Cohen, a neurologist and medical director at the Toronto Memory Program, emphasised the importance of this treatment in altering the course of Alzheimer’s disease. “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,” she stated, highlighting the drug’s potential to help patients maintain their independence.
However, it is critical to note that Health Canada has placed restrictions on Donanemab’s use, limiting it to adults who do not carry the APOE4 gene, a genetic variant that significantly heightens the risk of developing dementia and is present in approximately one-fifth of the global population.
Future Access and Funding Concerns
In addition to its regulatory approval, Canada’s Drug Agency will now evaluate whether Donanemab should be included in provincial and territorial drug formularies. The Alzheimer Society of Canada has pledged to advocate for public funding of the drug, but cautioned that the process for new medications to receive public coverage can often take up to two years following regulatory approval. Conversely, patients with private insurance or extended health benefits may have more immediate access to this treatment.
Side effects associated with Donanemab may include amyloid-related imaging abnormalities (ARIA), which can manifest as temporary swelling in various brain regions.
Why it Matters
The approval of Donanemab represents a critical advancement in the fight against Alzheimer’s disease, offering renewed hope for individuals diagnosed in the early stages and their families. As the healthcare community continues to advocate for broader access to such treatments, it underscores the essential role of research and policy in addressing the challenges posed by neurodegenerative diseases. Ensuring equitable access to innovative therapies will be vital in improving the quality of life for those affected by Alzheimer’s, ultimately fostering a more supportive environment for patients and caregivers alike.
