Health Canada Approves Leqembi for Early Alzheimer's Treatment

Health Canada has granted conditional approval for Leqembi (lecanemab), a treatment developed by Eisai and Biogen, for adults with early-stage Alzheimer's disease who have mild cognitive impairment or mild dementia and are non-carriers or heterozygotes of the ApoE ε4 gene with confirmed amyloid pathology. Leqembi is the first treatment authorized in Canada that targets an underlying cause of Alzheimer's by selectively binding to soluble and insoluble amyloid-beta aggregates, reducing their presence in the brain, and has been shown to slow cognitive and functional decline. This approval follows positive results from the global Phase 3 Clarity AD study, where Leqembi met primary and key secondary endpoints with statistical significance. The drug is already approved in 51 countries, including the U.S., Japan, Europe, China, and South Korea, with applications pending in nine additional countries. Alzheimer's disease is the most common form of dementia, affecting a growing population in Canada, which underscores the significance of this new treatment option. Eisai plans to continue collecting clinical assessment data from real-world use to verify Leqembi's clinical benefits further.