In a significant advancement for Alzheimer’s treatment, Health Canada has granted approval for donanemab, marketed as Kisunla by Eli Lilly. This announcement, made on Monday, marks the second drug approved in Canada aimed at slowing the progression of Alzheimer’s disease, following the approval of lecanemab, known as Leqembi, in October 2025. This development is poised to provide new options for individuals in the early stages of this debilitating condition.
Breakthrough in Alzheimer’s Treatment
The approval of donanemab is a pivotal moment in the ongoing battle against Alzheimer’s, a disease that affects millions worldwide. Donanemab works by targeting amyloid proteins, which are known to accumulate in the brain during the early phases of Alzheimer’s and are associated with cognitive decline. While the drug is not a cure, clinical trials have shown promising results, indicating that it may slow the deterioration of memory, cognitive abilities, and daily functioning in patients.
According to the Alzheimer’s Society of Canada, individuals in the early stages of the disease stand to benefit the most from donanemab. In clinical trials, participants demonstrated a 35 per cent reduction in decline on the integrated Alzheimer’s Disease Rating Scale (iADRS) over 18 months. For the broader patient population, the drug exhibited a 22 per cent slowing of disease progression, a testament to its potential impact.
Insights from Clinical Trials
Eli Lilly has highlighted encouraging findings from its clinical trials. Patients treated with Kisunla often experienced significant improvements, with many able to discontinue their treatment once amyloid plaques were cleared from their brains. Notably, some participants ceased treatment after just six months, while nearly half stopped after a year.
Dr. Sharon Cohen, a neurologist and medical director at the Toronto Memory Program, emphasised the importance of this drug in helping patients maintain their independence. “Changing the downward trajectory of Alzheimer’s disease is of the utmost importance,” she stated. “Individuals at early stages of this disease live in their own homes and lead robust lives but often dread what is to come.”
Safety and Accessibility Considerations
Despite the promising results, there are restrictions on the use of donanemab. Health Canada has limited its administration to adults who do not carry the APOE4 gene, a variant that significantly heightens the risk of developing dementia and is found in approximately 20 per cent of the global population. Additionally, potential side effects may include amyloid-related imaging abnormalities (ARIA), which can manifest as temporary swelling in certain brain areas.
As the approval process continues, Canada’s Drug Agency will evaluate whether donanemab should receive funding through provincial and territorial drug plans. The Alzheimer’s Society of Canada has pledged to advocate for public coverage of the drug, although it cautions that it could take up to two years for new medications to become publicly funded after receiving regulatory approval.
The Path Ahead
The approval of donanemab is viewed as a hopeful milestone for individuals diagnosed with early Alzheimer’s and their caregivers. Christina Scicluna, CEO of the Alzheimer Society of Canada, remarked, “While not a cure, it shows how far we’ve come and why research and advocacy matter. Together with our partners across Canada, we remain focused on ensuring people can access new treatments alongside the practical supports they need to navigate what comes next.”
As discussions about funding and accessibility proceed, many eyes will be on the evolving landscape of Alzheimer’s treatment options. The potential impact of donanemab on patient quality of life cannot be overstated, making this a crucial moment for those living with the disease.
Why it Matters
The approval of donanemab represents a significant step forward in the fight against Alzheimer’s disease, offering hope to countless individuals and families affected by this condition. As we navigate the complexities of healthcare access and treatment availability, it is imperative that we continue to advocate for equitable access to these groundbreaking therapies. Ensuring that all patients, regardless of genetic predisposition or economic status, can benefit from advancements in Alzheimer’s treatment is vital for fostering a more inclusive and supportive healthcare system.