Japan – “LEQEMBI(R)” (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease Approved in the United Kingdom

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

TOKYO and CAMBRIDGE, Mass., Nov 14, 2025 – (JCN Newswire) – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate head office: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) revealed today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI ®” (generic name: lecanemab) has actually been authorized for when every 4 weeks intravenous (IV) upkeep dosing by the Medicines and Healthcare items Regulatory Agency (MHRA) in the United Kingdom.

In August 2024, LEQEMBI was authorized for the treatment of moderate cognitive disability (MCI) and moderate dementia due to Alzheimer’s illness (ADVERTISEMENT) in adult clients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers in the United Kingdom. With this newest approval for IV upkeep dosing, after 18 months of a dosing program of 10 mg/kg as soon as every 2 weeks clients might be transitioned to the upkeep dosing program of 10 mg/kg when every 4 weeks, or the program of 10 mg/kg as soon as every 2 weeks might be continued.

Advertisement is a progressive, ruthless illness defined by development of protein deposits called plaques made from amyloid-beta aggregates and neurofibrillary tangles made from tau protein in the brains of individuals coping with advertisement. It is brought on by a constant underlying neurotoxic procedure that starts before amyloid plaque build-up and continues after plaque elimination.1,2 The information reveal that amyloid-beta protofibrils and tau tangles play functions in the neurodegeneration procedure,2,3 and just LEQEMBI battles advertisement in 2 methods– targeting both amyloid plaque and protofibrils **, which can affect tau downstream.

Due to the reaccumulation of advertisement biomarkers and go back to placebo rate of decrease after treatment is stopped,3-5 continuing upkeep treatment after the preliminary 18-month treatment is important to slow the development of advertisement and extend the restorative advantages, assisting clients preserve who they are for longer.

In the United Kingdom, it is approximated that 982,000 individuals are dealing with dementia,6 and advertisement is the cause in 60-70% of individuals with dementia.7 These numbers are anticipated to increase, as the population ages.6, 7

Eisai works as the lead for lecanemab’s advancement and regulative submissions worldwide with Eisai and Biogen co-commercializing and co-promoting the item and Eisai having last decision-making authority.

* Apolipoprotein E is a protein associated with the metabolic process of lipid in human beings. It is linked in advertisement. Individuals with just one (heterozygous) or no copy (non-carriers) of the ApoE ε4 gene are less most likely to experience ARIA than individuals with 2 ApoE ε4 copies (homozygous).8

** Protofibrils are believed to be the most harmful Aβ types that add to mental retardation in advertisement and play a significant function in the cognitive decrease of this progressive and terrible illness. Protofibrils can trigger neuronal and synaptic damage in the brain, which can consequently negatively impact cognitive function through several systems.3 The system by which this takes place has actually been reported not just by increasing the development of insoluble Aβ plaques, however likewise by straight harmful signaling in between nerve cells and other cells. It is thought that minimizing protofibrils might lower neuronal damage and cognitive disability, possibly slowing the development of advertisement.4

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Lecanemab is the outcome of a tactical research study alliance in between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed versus aggregated soluble (protofibril) and insoluble kinds of amyloid-beta (Aβ).

Lecanemab has actually been authorized in 51 nations and is under regulative evaluation in 9 nations. Following the preliminary stage with treatment every 2 weeks for 18 months, intravenous (IV) upkeep dosing with treatment every 4 weeks was authorized in the United Kingdom, the U.S, China and others, and applications have actually been submitted in 4 nations and areas.

LEQEMBI’s approvals in these nations were based upon Phase 3 information from Eisai’s, worldwide Clarity advertisement medical trial, in which it fulfilled its main endpoint and all crucial secondary endpoints with statistically considerable outcomes. The main endpoint was the international cognitive and practical scale, Clinical Dementia Rating Sum of Boxes (CDR-SB).1 The U.S. FDA authorized Eisai’s Biologics License Application (BLA) for subcutaneous upkeep dosing with LEQEMBI IQLIK in August 2025. In September 2025, the rolling sBLA application to the U.S. FDA for the subcutaneous initiation dosing with LEQEMBI IQLIK was likewise started.

Given that July 2020 the Phase 3 scientific research study (AHEAD 3-45) for people with preclinical advertisement, suggesting they are medically regular and have intermediate or raised levels of amyloid in their brains, is continuous. AHEAD 3-45 is performed as a public-private collaboration in between the Alzheimer’s Clinical Trial Consortium that offers the facilities for scholastic scientific trials in advertisement and associated dementias in the U.S, moneyed by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Given that January 2022, the Tau NexGen scientific research study for Dominantly Inherited Advertisement (DIAD), that is performed by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is continuous and consists of lecanemab as the foundation anti-amyloid treatment.

For more information, please check out: https://www.eisai.com/news/2025/pdf/enews202579pdf.pdf