BioArctic AB's partner Eisai announced today that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Leqembi (Lecanemab) for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease (early AD) who are apolipoprotein E ε4 (ApoE ε41) non-carriers or heterozygotes and who have confirmed amyloid pathology. LEQEMBI is the first treatment for early AD that targets an underlying cause of the disease, to be authorised in Canada.

Leqembi selectively binds to soluble Aβ aggregates (protofibrilsi), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. Leqembi is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer's disease. Leqembi is approved in 51 countries and regions including Japan, the United States, Europe, China, South Korea, Taiwan, and Saudi Arabia, and applications have been filed in nine countries.

The approval of Leqembi is based on the large global phase 3 Clarity AD study. In the Clarity AD study, Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results. It has been issued market authorisation in Canada with conditions, pending the results of trials to verify its clinical benefit. Eisai plans to submit clinical assessment data captured from participants in real-world clinical practice.

Alzheimer's Disease is the most common form of dementia, accounting for 60 to 80 percent of all cases. As of January 1, 2025, it is estimated there are more than 771,000 patients with dementia in Canada, which is expected to increase to approximately one million in 2030 and over 1.7 million in 2050. In addition, annual care provided by family and friends for those with dementia is equivalent to 290,000 full-time jobs, which is expected to increase to 690,000 full-time jobs in 2050.

Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialisation of Leqembi for Alzheimer's disease. BioArctic has the right to commercialise Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialisation in the region.