Health Canada Grants Authorization for Leqembi® (lecanemab)

Core Insights - Health Canada has granted a Notice of Compliance with Conditions for Leqembi® (lecanemab), marking it as the first treatment for early Alzheimer's disease authorized in Canada targeting the underlying cause of the disease [1][18] - Leqembi has shown significant efficacy in reducing disease progression and cognitive decline in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease [2][7] Company Overview - BioArctic AB and Eisai have a long-standing collaboration since 2005, focusing on the development and commercialization of Alzheimer's disease treatments, with Eisai responsible for clinical development and market applications [5][11] - BioArctic retains commercialization rights for Leqembi in the Nordic region and is preparing for joint commercialization with Eisai [5][11] Clinical Data - The approval of Leqembi is based on the Phase 3 Clarity AD study, which demonstrated statistically significant results in meeting primary and secondary endpoints [3][7] - The Clarity AD study involved 1,795 patients with early Alzheimer's disease, confirming the presence of amyloid pathology, and utilized a bi-weekly dosing regimen of 10 mg/kg for 18 months [7][8] Market Context - Alzheimer's disease accounts for 60 to 80% of all dementia cases, with over 771,000 dementia patients in Canada as of January 1, 2025, projected to rise to approximately 1 million by 2030 [4] - The annual care provided by family and friends for dementia patients is equivalent to 290,000 full-time jobs, expected to increase to 690,000 by 2050 [4] Product Information - Leqembi selectively binds to both soluble and insoluble amyloid-beta aggregates, reducing their presence in the brain, which is crucial for slowing cognitive decline [2][16] - The drug is approved in 51 countries, including the U.S., Japan, and the EU, and is under review in 9 additional countries [2][8]