Health Canada has granted approval for Donanemab, a new treatment aimed at slowing the progression of Alzheimer’s disease. Developed by the American pharmaceutical company Eli Lilly and marketed under the brand name Kisunla, this drug is now the second of its kind to receive endorsement in Canada. The approval comes after a similar decision for Lecanemab, known commercially as Leqembi, which was sanctioned in October 2025.
Understanding Donanemab and Its Mechanism
Donanemab works by targeting amyloid plaques, the sticky proteins that accumulate in the brains of individuals suffering from Alzheimer’s. This accumulation is believed to contribute to cognitive decline, affecting memory and overall mental functions. While the treatment is not a cure, clinical trials indicate that it can potentially decelerate the deterioration of cognitive abilities in some patients, particularly those in the early stages of the disease.
According to the Alzheimer Society of Canada, the results from clinical trials have shown promising outcomes. Participants who took Kisunla demonstrated a significant slowing of cognitive decline—35 per cent for those with less advanced disease, as measured by the integrated Alzheimer’s Disease Rating Scale (iADRS). Overall, the drug resulted in a 22 per cent reduction in the progression of the disease across the broader patient population.
Clinical Trial Insights
The clinical trials also revealed that patients could stop treatment after amyloid plaques were effectively cleared, with some participants discontinuing therapy within just six months. Nearly 50 per cent of patients ceased treatment after one year, highlighting the drug’s effectiveness in certain cases. Eli Lilly has noted that early-stage patients experienced the most considerable benefits, providing hope for those navigating the early phases of Alzheimer’s.
Christina Scicluna, CEO of the Alzheimer Society of Canada, hailed the approval as a significant milestone for individuals living with the disease and their caregivers. “While not a cure, it shows how far we’ve come and underscores the importance of research and advocacy,” she stated, emphasising the need for accessible treatments and support systems for patients and their families.
Safety and Accessibility Considerations
Health Canada has placed restrictions on the use of Donanemab, limiting it to adults who do not carry the APOE4 gene, which is linked to an increased risk of dementia and is present in approximately one-fifth of the global population. Potential side effects include amyloid-related imaging abnormalities (ARIA), which can manifest as temporary swelling in specific brain regions.
The next step will involve Canada’s Drug Agency assessing whether Donanemab should be included in provincial and territorial drug plans. The Alzheimer Society of Canada intends to advocate for public coverage of the drug, although they caution that it may take up to two years for newly approved medications to be funded through public health systems. Meanwhile, those with private insurance may gain quicker access to this important treatment.
Why it Matters
The approval of Donanemab represents a significant advancement in the fight against Alzheimer’s disease, providing hope to those affected by this debilitating condition. With a growing population of individuals facing cognitive decline, it is crucial to ensure that effective treatments are both accessible and supported by healthcare systems. As the conversation around Alzheimer’s evolves, the need for continuous research, advocacy, and comprehensive care becomes ever more critical. The introduction of Donanemab not only underscores the progress being made in medical science but also highlights the ongoing challenges faced by patients and their families in navigating this complex disease landscape.
