STOCKHOLM – September 04, 2026 -- Canada's Drug Agency (CDA-AMC) has issued a final recommendation supporting public reimbursement of Leqembi (lecanemab) for patients with mild cognitive impairment or mild dementia due to early Alzheimer's disease, BioArctic AB's partner Eisai announced.
Final recommendation follows agency reconsideration process
The decision comes after CDA-AMC reconsidered its position on the drug, marking a step toward broader patient access in Canada. Negotiations will now proceed through the pan-Canadian Pharmaceutical Alliance, followed by individual reimbursement decisions from public drug plans across Canada's provinces and territories.
Canadian dementia population set to more than double by 2050
More than 770,000 people in Canada were estimated to be living with dementia in 2025, a figure the Alzheimer Society of Canada projects will rise to 1.7 million by 2050. The reimbursement pathway targets patients in the early stages of Alzheimer's disease, where the drug is intended to slow cognitive decline.
Leqembi already cleared in 53 countries with China filing under priority review
Leqembi is approved in 53 countries and remains under regulatory review in six others. Intravenous maintenance dosing every four weeks is approved in eight markets including the US, UK, China and Japan, with applications filed in 12 additional countries and regions. In the US, a subcutaneous autoinjector formulation, Leqembi Iqlik, is approved for both starting and maintenance treatment. China accepted a Biologics License Application for the subcutaneous formulation in January 2026 and granted it priority review the following month, while Japan received a subcutaneous initiation-treatment filing in November 2025.
BioArctic collects royalties without bearing Alzheimer's development costs
Under a collaboration dating to 2005, BioArctic invented lecanemab and holds Nordic commercialization rights for the drug, while Eisai manages global regulatory interactions and commercialization. BioArctic carries no development costs for lecanemab in Alzheimer's disease and is entitled to sales-milestone payments plus royalties on global revenue. The Development and Commercialization agreement for the antibody was signed in 2007, with a related back-up antibody agreement following in 2015; Eisai and Biogen entered a separate joint development and commercialization agreement for lecanemab in 2014.