BioArctic AB (publ) announced that its partner Eisai has received a Notice of Compliance with Conditions (NOC/c) from Health Canada for Leqembi (lecanemab) for the treatment of adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease (early AD). The authorization applies to ApoE e4 non-carriers or heterozygotes with confirmed amyloid pathology.
Leqembi becomes the first treatment in Canada targeting an underlying cause of Alzheimer’s disease, marking a significant advancement in the management of early AD.
Leqembi is a humanized monoclonal antibody designed to bind selectively to soluble Aβ protofibrils and insoluble Aβ fibrils, which are key components of amyloid plaques in the brain. This dual action helps reduce amyloid buildup and slow disease progression, addressing one of the central drivers of Alzheimer’s pathology.
The approval is supported by data from the global Phase 3 Clarity AD study, in which Leqembi met its primary and all key secondary endpoints with statistically significant results. Health Canada’s conditional market authorization is pending further verification of clinical benefit through ongoing studies and real-world evidence submissions from Eisai.
Leqembi is now approved in 51 countries and regions, including the United States, Japan, the European Union, China, South Korea, Taiwan, and Saudi Arabia, with regulatory reviews ongoing in nine additional countries.
In clinical trials, Leqembi was the first therapy proven to reduce cognitive and functional decline in patients with early-stage Alzheimer’s disease. The standard regimen involves bi-weekly intravenous infusions for 18 months, followed by a maintenance dose every four weeks. A subcutaneous formulation (Leqembi Iqlik) has been approved for maintenance use in the U.S., with additional applications underway globally.
Eisai continues to investigate lecanemab in broader Alzheimer’s populations:
Leqembi originates from BioArctic’s research, based on the discovery of the Arctic mutation in Alzheimer’s disease by Professor Lars Lannfelt. The antibody was co-developed under a 2007 development and commercialization agreement between BioArctic and Eisai. Eisai oversees global development, regulatory submissions, and commercialization, while BioArctic retains commercialization rights in the Nordic region, where joint launch preparations are underway.
BioArctic incurs no development costs for Leqembi and is entitled to milestone payments, royalties on global sales, and regulatory approval payments.
Alzheimer’s disease is the most common form of dementia, responsible for 60–80% of all cases. In Canada, more than 771,000 people live with dementia as of 2025 — a number projected to reach 1 million by 2030 and 1.7 million by 2050. The annual care provided by family and friends already equals 290,000 full-time jobs, expected to more than double by 2050.
Leqembi is a humanized IgG1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid-beta (Aβ). It was co-developed by BioArctic and Eisai and is marketed by Eisai globally.
BioArctic AB (publ) is a Swedish research-based biopharmaceutical company developing innovative treatments for neurodegenerative diseases. The company invented Leqembi (lecanemab) – the world’s first drug proven to slow disease progression and reduce cognitive impairment in early Alzheimer’s disease.
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