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].

Core Viewpoint - Eisai Co., Ltd. and Biogen Inc. have launched the anti-amyloid beta monoclonal antibody "LEQEMBI" in Austria and will launch it in Germany, marking the first launches in the EU after receiving European Commission approval in April 2025 for treating early Alzheimer's disease [1][2]. Company Overview - Eisai serves as the lead for the development and regulatory submissions of lecanemab globally, with both Eisai and Biogen co-commercializing and co-promoting the product [6][16]. - Biogen, founded in 1978, is a leading biotechnology company focused on innovative science to deliver new medicines and create value for shareholders [20]. Product Details - LEQEMBI targets both amyloid plaque and protofibrils, addressing a significant unmet need for new treatment options that slow the progression of Alzheimer's disease [3][9]. - The Clarity AD clinical trial demonstrated that treatment with lecanemab reduced clinical decline on the Clinical Dementia Rating – Sum of Boxes (CDR-SB) by 31% at 18 months compared to placebo [4][12]. Clinical Trial Insights - The Clarity AD trial involved 1,795 patients with early Alzheimer's disease, with 1,521 in the EU indicated population (ApoE ε4 non-carriers or heterozygotes) [12]. - The most common adverse reactions in the EU indicated population included infusion-related reactions (26%), ARIA-H (13%), headache (11%), and ARIA-E (9%) [5][12]. Regulatory and Market Context - LEQEMBI has been approved in 48 countries and is under regulatory review in 10 countries, with a supplemental Biologics License Application for intravenous maintenance dosing approved in the U.S. [13][12]. - The controlled access program is in place in Austria and Germany to ensure patient safety and appropriate use of the medicine [2][8].

Core Insights - Biogen Inc. will present significant data at the 2025 Alzheimer's Association International Conference (AAIC) regarding LEQEMBI (lecanemab) and BIIB080, focusing on long-term results and new treatment formulations [1][2][6] Group 1: LEQEMBI (lecanemab) Developments - The upcoming presentations will include 48-month results from the Clarity AD open-label extension, real-world evidence, and insights into a subcutaneous formulation for maintenance dosing of LEQEMBI [1][2][6] - LEQEMBI is a humanized IgG1 monoclonal antibody targeting amyloid-beta, which received traditional FDA approval on July 6, 2023, for treating Alzheimer's disease [8][9] Group 2: BIIB080 Investigational Therapy - BIIB080 is an investigational antisense oligonucleotide (ASO) therapy targeting tau protein, currently in a Phase 2 clinical study for early Alzheimer's disease [5][6] - The CELIA trial will provide baseline characteristics of participants, contributing to the understanding of tau-targeted therapies [2][7] Group 3: Educational Initiatives - Biogen will host an interactive booth at AAIC to educate attendees on the role of tau in Alzheimer's disease and will launch a new e-learning module on KnowTau.com [4][6] - The educational program aims to bridge research and clinical practice regarding tau therapies and biomarkers [7]