LEQEMBI® (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Australia

Core Viewpoint - Eisai Co., Ltd. and Biogen Inc. announced the approval of LEQEMBI (lecanemab) by the Therapeutic Goods Administration (TGA) of Australia for treating mild cognitive impairment or mild dementia due to Alzheimer's disease in specific adult populations [1][2]. Group 1: Product Approval and Clinical Data - The approval of LEQEMBI was based on Phase 3 data from the Clarity AD clinical trial, which demonstrated a 33% reduction in clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale at 18 months compared to placebo [9]. - The Clarity AD trial involved 1,795 patients with early Alzheimer's disease, with 1,521 patients in the Australian indicated population [9]. - LEQEMBI has been approved in 50 countries and is under regulatory review in 8 countries, with significant results from the global Clarity AD clinical trial [8]. Group 2: Alzheimer's Disease Context - In Australia, the number of people living with dementia is estimated to rise from approximately 425,000 in 2024 to nearly 1,100,000 by 2065, with Alzheimer's disease accounting for 60-70% of dementia cases [3]. - Alzheimer's disease is characterized by a progressive neurotoxic process involving amyloid beta (Aβ) and tau, with LEQEMBI targeting both toxic protofibrils and amyloid plaques [3][8]. Group 3: Collaboration and Development - Eisai leads the global development and regulatory submissions for lecanemab, with Biogen co-commercializing and co-promoting the product [4][12]. - Eisai and BioArctic have collaborated since 2005 on the development and commercialization of Alzheimer's disease treatments, with Eisai obtaining global rights for lecanemab in 2007 [13].