In a significant advancement for Alzheimer’s care, Health Canada has granted approval to donanemab, marketed as Kisunla by Eli Lilly, as a treatment aimed at slowing the progression of this debilitating disease. Announced on Monday, this marks the second drug of its kind to receive endorsement in Canada, following the earlier approval of lecanemab, also known as Leqembi, in October 2025. As Alzheimer’s continues to impact countless individuals and families, this development offers a glimmer of hope for early-stage patients.
Understanding Donanemab’s Mechanism
Like its predecessor lecanemab, donanemab targets amyloid plaques—sticky proteins that accumulate in the brain during the initial phases of Alzheimer’s disease. The presence of these plaques is closely linked to cognitive decline, affecting memory and overall thinking abilities. While neither drug is a definitive cure, early clinical trials suggest that donanemab may help delay the deterioration of cognitive functions for certain individuals who are at the onset of the disease.
Eli Lilly’s clinical research indicates that some patients may discontinue treatment after their amyloid levels have been sufficiently reduced, with a notable proportion stopping within six months, and nearly half ceasing treatment after a year. This suggests that donanemab might not only slow the disease’s progression but also offer a pathway to maintain quality of life.
Clinical Trial Results
In trials lasting eighteen months, participants with milder symptoms experienced a remarkable 35 per cent reduction in their cognitive decline, as measured by the integrated Alzheimer’s Disease Rating Scale (iADRS), which evaluates memory, thinking, and daily functioning. More broadly, across all participants, donanemab demonstrated a 22 per cent slowing of disease progression.
Christina Scicluna, CEO of the Alzheimer Society of Canada, heralded this approval as a promising milestone for individuals at the beginning stages of Alzheimer’s and their caregivers. She stated, “While not a cure, it shows how far we’ve come and why research and advocacy matter.” This sentiment echoes through the community, underscoring the urgent need for accessible treatments alongside supportive resources for patients.
Limitations and Future Considerations
It’s important to note that Health Canada has restricted the use of donanemab to adults who do not carry the APOE4 gene, a genetic variant present in approximately 20 per cent of the global population that significantly heightens the risk of developing Alzheimer’s. Patients considering this treatment should be aware of potential side effects, which may include amyloid-related imaging abnormalities (ARIA), manifesting as temporary swelling in the brain.
As the next step, Canada’s Drug Agency will evaluate whether donanemab should receive funding through provincial and territorial drug plans. The Alzheimer Society of Canada plans to advocate for its inclusion in public coverage, acknowledging that the process from regulatory approval to public funding can extend up to two years. Meanwhile, those with private insurance often find themselves able to access treatments more swiftly.
Why it Matters
The approval of donanemab is a beacon of hope for individuals grappling with early-stage Alzheimer’s and their families. With an emphasis on maintaining independence and quality of life, this treatment not only has the potential to slow cognitive decline but also reinforces the importance of ongoing research and advocacy in healthcare. As Canada continues to navigate the complexities of Alzheimer’s disease, the integration of new therapies like donanemab into patient care represents a meaningful stride forward in the fight against this pervasive condition.