Health Canada has recently granted approval for Donanemab, a promising new medication aimed at slowing the progression of Alzheimer’s disease. Manufactured by Eli Lilly under the brand name Kisunla, this innovative treatment joins Lecanemab, known commercially as Leqembi, as the second drug of its kind approved in Canada. The announcement, made on Monday, follows its earlier endorsement by the U.S. Food and Drug Administration in 2024.
Targeting Amyloid Plaques
Both Donanemab and Lecanemab are designed to address the underlying pathology of Alzheimer’s by targeting amyloid beta plaques—sticky proteins that accumulate in the brain and are associated with cognitive decline. The presence of these plaques can lead to significant impairments in memory and cognitive function, particularly in the early stages of the disease.
Although Donanemab is not a cure, clinical trials have shown it can substantially slow the cognitive decline experienced by patients in the early phases of Alzheimer’s. According to the Alzheimer Society of Canada, evidence suggests that some patients experienced notable improvements in memory, thinking, and daily functioning as a result of the treatment.
Clinical Trial Findings
In trials involving Kisunla, patients were able to halt treatment after their amyloid levels returned to normal, with some discontinuing therapy after as little as six months. Eli Lilly reported that nearly 50% of participants stopped treatment within 12 months, indicating the drug’s effectiveness in clearing amyloid plaques. The most significant benefits were observed in individuals who were less advanced in their disease progression, with a reported 35% reduction in cognitive decline over 18 months, as measured by the integrated Alzheimer’s Disease Rating Scale (iADRS). For the broader patient population, the drug demonstrated a 22% slowing of Alzheimer’s progression.
Reactions from Experts and Advocacy Groups
Christina Scicluna, CEO of the Alzheimer Society of Canada, emphasized the importance of this approval, calling it a “hopeful milestone” for those living with early Alzheimer’s and their caregivers. She 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.”
Dr. Sharon Cohen, a neurologist and medical director at the Toronto Memory Program, highlighted the potential for Donanemab to help patients maintain their independence. “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,” she stated.
Limitations and Future Access
Health Canada has imposed certain restrictions on the use of Donanemab, allowing treatment only for adults who do not carry the APOE4 gene, a genetic variant linked to a significantly increased risk of dementia. Potential side effects include amyloid-related imaging abnormalities (ARIA), which can manifest as temporary swelling in certain areas of the brain.
Following this approval, Canada’s Drug Agency will evaluate whether Donanemab will be included in provincial and territorial drug plans. The Alzheimer Society of Canada has pledged to advocate for public coverage of the drug but cautioned that it may take up to two years for new treatments to become available through public drug plans. Meanwhile, patients with private insurance may access the treatment more swiftly.
Why it Matters
The approval of Donanemab represents a critical advancement in the fight against Alzheimer’s disease, offering new hope to those diagnosed and their families. As Canada grapples with an increasing number of individuals affected by this debilitating condition, the introduction of effective treatments like Donanemab can significantly impact the quality of life for patients. Ensuring accessibility and affordability of such therapies is paramount, as it not only reflects our commitment to healthcare innovation but also underscores the societal imperative to support those navigating the challenges of early Alzheimer’s.
