Health Canada has greenlit the use of donanemab, a groundbreaking drug designed to slow the advancement of Alzheimer’s disease. The medication, marketed as Kisunla by the American pharmaceutical company Eli Lilly, received official approval on Monday. This marks a significant development in Alzheimer’s treatment, following the earlier endorsement of lecanemab, known commercially as Leqembi, in October 2025.
A New Hope in Alzheimer’s Treatment
Donanemab operates similarly to lecanemab, targeting amyloid proteins that accumulate in the brain during the early stages of Alzheimer’s. This accumulation is closely linked to cognitive impairments, such as memory loss and difficulties with thinking. While neither drug is a definitive cure, clinical trials have demonstrated the potential of donanemab to slow cognitive decline in patients at the onset of the disease.
The Alzheimer Society of Canada has recognised the drug’s promise, noting that it may provide substantial benefits for individuals in the early stages of Alzheimer’s. “While not a cure, it shows how far we’ve come and why research and advocacy matter,” stated Christina Scicluna, CEO of the Alzheimer Society of Canada.
Efficacy and Clinical Findings
Clinical trials of Kisunla revealed compelling results, particularly for patients in the initial phases of Alzheimer’s. Participants experienced a 35 per cent slowdown in cognitive decline over 18 months, as measured by the integrated Alzheimer’s Disease Rating Scale (iADRS), which evaluates memory and daily functioning. For the broader patient population, the drug showed a 22 per cent reduction in disease progression.
Eli Lilly reported that patients treated with donanemab could cease treatment once amyloid plaques were sufficiently cleared from their brains. Remarkably, some participants were able to stop treatment after just six months, with nearly half discontinuing after one year.
Dr. Sharon Cohen, a neurologist and medical director at the Toronto Memory Program, emphasised the importance of this development, stating, “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.”
Regulatory Considerations and Future Access
Despite this significant stride forward, Health Canada has imposed restrictions on the use of donanemab, limiting it to adults who do not possess the APOE4 gene. This genetic variant, which affects approximately 20 per cent of the global population, significantly raises the likelihood of developing dementia.
Moreover, potential side effects, such as amyloid-related imaging abnormalities (ARIA), may manifest as temporary swelling in specific brain areas. Following this approval, Canada’s Drug Agency will evaluate whether donanemab will receive funding through provincial and territorial drug plans.
The Alzheimer Society of Canada is committed to advocating for the drug’s inclusion in public drug coverage, although it cautions that the process may take up to two years post-approval. For individuals with private insurance, access to this vital treatment may arrive more swiftly.
Why it Matters
The approval of donanemab represents a beacon of hope for those grappling with early-stage Alzheimer’s and their caregivers. As the healthcare landscape evolves, the availability of innovative treatments like Kisunla is crucial in maintaining the quality of life for patients. As advocates continue to push for equitable access to these therapies, the battle against Alzheimer’s disease gains momentum, underscoring the pressing need for ongoing research, policy support, and public awareness.
