“LEQEMBI®” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Approved in the United Kingdom

Core Insights - Eisai Co., Ltd. and Biogen Inc. announced the approval of LEQEMBI® (lecanemab) for once every four weeks intravenous maintenance dosing in the UK, following its earlier approval for treating mild cognitive impairment and mild dementia due to Alzheimer's disease [1][2]. Group 1: Product Approval and Usage - LEQEMBI was initially approved in August 2024 for treating mild cognitive impairment and mild dementia in adult patients who are either apolipoprotein E ε4 heterozygotes or non-carriers [2]. - The new maintenance dosing regimen allows patients to transition from an 18-month treatment of 10 mg/kg every two weeks to 10 mg/kg every four weeks, or to continue the bi-weekly regimen [2]. Group 2: Alzheimer's Disease Context - Alzheimer's disease (AD) is characterized by amyloid-beta plaques and tau protein tangles in the brain, leading to neurodegeneration [3]. - LEQEMBI targets both amyloid plaques and protofibrils, which are believed to contribute to cognitive decline, making ongoing maintenance treatment crucial for slowing AD progression [3][5]. Group 3: Market and Demographics - In the UK, approximately 982,000 individuals are living with dementia, with AD being the cause in 60-70% of these cases, and these numbers are expected to rise with an aging population [4]. Group 4: Development and Collaboration - Eisai leads the global development and regulatory submissions for lecanemab, with both Eisai and Biogen co-commercializing and promoting the product [4][10]. - Lecanemab has been approved in 51 countries and is under regulatory review in 9 additional countries, indicating a broad international interest and potential market [7].