#Canada #Stockholm #Lecanemab #Leqembi #Alzheimer's

Health Canada Approves Leqembi® (lecanemab)

On October 26, 2025, BioArctic AB’s partner, Eisai, announced that Health Canada has granted a Notice of Compliance with Conditions (NOC/c) for Leqembi® (lecanemab) to treat adult patients diagnosed with mild cognitive impairment or mild dementia due to Alzheimer's disease (AD). This groundbreaking treatment is the first to target an underlying cause of early Alzheimer's disease, specifically for patients who are apolipoprotein E ε4 non-carriers or heterozygotes and have confirmed amyloid pathology.

A Groundbreaking Treatment for Alzheimer's Disease

Leqembi targets both soluble and insoluble aggregates of amyloid-beta (Aβ), which are key components of amyloid plaques in the brain. By binding selectively to these aggregates, Leqembi effectively reduces the levels of both Aβ protofibrils and plaques, which are believed to contribute to cognitive decline in Alzheimer’s patients. This treatment has been shown to slow disease progression and mitigate cognitive and functional decline, which is a significant advancement in Alzheimer's therapy.

Approved in 51 countries worldwide, Leqembi has already received market authorization in major regions, including the United States, Europe, Japan, and China. It is currently under regulatory review in nine additional countries. The approval in Canada is notably based on the large global Phase 3 Clarity AD study, where Leqembi met its primary endpoint with statistically significant results, demonstrating its effectiveness in slowing the progress of Alzheimer's disease.

The Rising Demand for Alzheimer's Care in Canada

The urgency surrounding Alzheimer's disease is increasing, particularly in Canada, where more than 771,000 patients were diagnosed as of January 1, 2025. This number is projected to soar to approximately 1 million by 2030 and over 1.7 million by 2050. Family caregivers provided an equivalent of 290,000 full-time jobs worth of care annually for those with dementia, a figure expected to rise drastically as the patient population expands. Amid this growing demand, the approval of Leqembi offers a ray of hope for patients and families grappling with this debilitating illness.

Eisai plans to collect clinical assessment data from real-world practice to further verify Leqembi's benefits. This commitment to ongoing evaluation underlines the importance of understanding how well the treatment performs outside controlled clinical settings.

Collaborative Development and Innovative Research

Leqembi is the product of an enduring collaboration between BioArctic and Eisai, initiated in 2005. The discovery centers on Professor Lars Lannfelt's research, particularly focusing on the Arctic mutation related to Alzheimer's. As the clinical development and commercialization leader for Leqembi, Eisai has successfully positioned the therapy within the global market. Meanwhile, BioArctic retains rights for commercialization within the Nordic regions, working closely with Eisai to support this effort.

The clinical development of Leqembi is not the only focus for BioArctic, a Swedish biopharma company devoted to innovative neurodegenerative disease therapies. Their ongoing research includes projects targeting Alzheimer's disease through unique technologies, such as their proprietary BrainTransporter™ designed to enhance drug delivery across the blood-brain barrier.

Conclusion

With Leqembi now authorized in Canada, the landscape for managing early Alzheimer's disease has begun to transform. As more data from clinical practice comes to light, stakeholders from healthcare professionals to families affected by Alzheimer's will eagerly anticipate the comprehensive benefits that Leqembi may provide. This approval is poised to make a significant impact on the standard of care for early Alzheimer's patients, offering renewed hope in the fight against this challenging disease.

For more information about BioArctic and its groundbreaking research, please visit their official website.