Health Canada has officially sanctioned a groundbreaking treatment for Alzheimer’s disease, namely donanemab, marketed as Kisunla by the American pharmaceutical giant Eli Lilly. This significant development marks the second approval of a drug designed to slow the progression of Alzheimer’s in Canada, following the endorsement of lecanemab, known commercially as Leqembi, in October 2025. The approval was announced on Monday, with the U.S. Food and Drug Administration having granted its nod back in 2024.
Targeting Alzheimer’s at Its Core
The primary mechanism of donanemab, like that of lecanemab, involves targeting amyloids—sticky proteins that accumulate in the brain during the early stages of Alzheimer’s disease. The presence of amyloid plaques is linked to cognitive decline, manifesting as memory loss and difficulties in thinking. Although donanemab is not a cure, clinical trials have shown promising results, particularly for those in the early phases of the disease. According to the Alzheimer’s Society of Canada, the drug has the potential to decelerate the decline in cognitive functions and daily activities for certain individuals.
In trials involving Kisunla, patients were able to cease treatment once amyloid plaques had been eliminated, with some discontinuing after just six months and nearly 50% stopping after a year. Eli Lilly noted that the most substantial benefits were observed in patients at the earlier stages of Alzheimer’s.
Positive Outcomes in Clinical Trials
Over an 18-month period, participants who were less advanced in their condition experienced a remarkable 35% reduction in cognitive decline as measured by the integrated Alzheimer’s Disease Rating Scale (iADRS), which gauges memory, thinking, and daily functioning. For the broader population enrolled in the trials, donanemab resulted in a 22% slowing of disease progression.
Christina Scicluna, CEO of the Alzheimer Society of Canada, heralded the approval as a ‘hopeful milestone’ for individuals living with early Alzheimer’s and their caregivers. She emphasised the importance of research and advocacy in achieving this landmark approval, highlighting the need for accessible treatments and support systems.
Expert Insights and Precautions
Dr. Sharon Cohen, a neurologist and medical director at the Toronto Memory Program, noted that the availability of this new therapy offers early-stage patients a crucial opportunity to preserve their independence. “Altering the downward trajectory of Alzheimer’s disease is vital,” she remarked, explaining that many individuals at this stage are able to live independently but are apprehensive about the future.
It is important to note that Health Canada has placed restrictions on the use of donanemab, allowing its prescription only for adults who do not carry the APOE4 gene, a variant that significantly heightens the risk of dementia and is found in approximately 20% of the global population. Potential side effects may include amyloid-related imaging abnormalities (ARIA), presenting as temporary swelling in affected areas of the brain.
Future Steps for Access
Following this regulatory approval, Canada’s Drug Agency will evaluate whether donanemab should be included in provincial and territorial drug plans. The Alzheimer’s Society of Canada is committed to advocating for public coverage of the drug, although they caution that it may take up to two years for new treatments to become publicly funded after regulatory approval. Meanwhile, those with private insurance or extended health benefits may gain faster access to this promising therapy.
Why it Matters
The approval of Kisunla is a beacon of hope in the ongoing battle against Alzheimer’s disease, offering new avenues for treatment to those affected and their families. As the number of individuals diagnosed with dementia continues to rise, advancements like donanemab are crucial in not only managing symptoms but also enhancing the quality of life for patients. Continued advocacy for equitable access to such treatments remains essential, ensuring that breakthroughs in medical research translate into tangible benefits for those who need them most.
