Leqembi® approved for IV maintenance treatment in the United Kingdom

Core Viewpoint - BioArctic AB's partner Eisai has received approval for Leqembi (lecanemab) for once every four weeks intravenous maintenance dosing for early Alzheimer's disease in the UK [1][15]. Group 1: Approval and Treatment Regimen - Leqembi was previously approved in August 2024 for treating mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease in specific patient groups in the UK [2]. - The new maintenance dosing allows patients to transition from an 18-month regimen of 10 mg/kg every two weeks to either 10 mg/kg every four weeks or continue with the bi-weekly regimen [2]. Group 2: Market Context and Demographics - Approximately 982,000 individuals in the UK are living with dementia, with Alzheimer's disease accounting for 60-70% of these cases, a number expected to rise with an aging population [3]. Group 3: Collaboration and Development - Leqembi is a product of a long-term collaboration between BioArctic and Eisai, with BioArctic having rights to commercialize the drug in the Nordic region [4][10]. - Eisai is responsible for clinical development, market approval applications, and commercialization globally, while BioArctic incurs no development costs for lecanemab [10]. Group 4: Regulatory Approvals and Clinical Trials - Lecanemab has been approved in 51 countries, including the US, Japan, China, and the EU, for early Alzheimer's disease treatment, with ongoing regulatory reviews in nine additional countries [6]. - The approvals were based on Phase 3 data from the Clarity AD clinical trial, which met its primary and key secondary endpoints with statistically significant results [7]. Group 5: Ongoing Research and Future Studies - Eisai's ongoing Phase 3 clinical study (AHEAD 3-45) involves individuals with preclinical Alzheimer's disease and is fully recruited as of October 2024 [8]. - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) is also ongoing and includes lecanemab as a key therapy [8].