Leqembi® approved for IV maintenance treatment in the United Kingdom
Leqembi® approved for IV maintenance treatment in the United Kingdom |
| [13-November-2025] |
STOCKHOLM, Nov. 13, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Leqembi (lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing for the treatment of early Alzheimer's disease by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. In August 2024, Leqembi was approved for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)[1] heterozygotes or non-carriers in the United Kingdom. With this latest approval for IV maintenance dosing, after 18 months of a dosing regimen of 10 mg/kg once every two weeks, patients may be transitioned to a maintenance dosing regimen of 10 mg/kg once every four weeks, or they may continue with 10 mg/kg once every two weeks . In the United Kingdom, an estimated 982,000 people are living with dementia,[2] with AD accounting for an estimated 60-70% of cases.[3] These numbers are expected to rise as the population ages. Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region. The information was released for public disclosure, through the agency of the contact person below, on November 14, 2025, at 00:30 a.m. CET. For further information, please contact: About lecanemab (Leqembi ®) Lecanemab is approved in 51 countries including the U.S., Japan, China, and the European Union for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) and is under regulatory review in 9 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in the United Kingdom, China, the U.S. and others, and applications have been filed in 4 countries and regions. Leqembi's approvals in these countries were based on Phase 3 data from Eisai's, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB).[4] Leqembi Iqlik™ is approved for subcutaneous dosing with an autoinjector for maintenance treatment of early Alzheimer's disease in the US. In September 2025, a rolling sBLA application for the subcutaneous initiation dosing with Leqembi Iqlik was also initiated to the U.S. FDA. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. About the collaboration between BioArctic and Eisai About BioArctic AB [1] Apolipoprotein E is a protein involved in the metabolism of lipid in humans. It is implicated in AD. People with only one (heterozygous) or no copy (non-carriers) of the ApoE ε4 gene are less likely to experience ARIA than people with two ApoE ε4 copies (homozygous). [2] Alzheimer's Society. 2024. The economic impact of dementia. Available at: https://www.alzheimers.org.uk/about-us/policy-and-influencing/dementia-scale-impact-numbers. Last accessed: August 2024. [3] World Health Organization. 2023. Dementia. Available at: https://www.who.int/news-room/fact-sheets/detail/dementia. Last accessed: August 2024 [4] Eisai presents full results of lecanemab Phase 3 confirmatory Clarity AD study for early Alzheimer's disease at Clinical Trials on Alzheimer's Disease (CTAD) conference. Available at: https://www.eisai.co.jp/news/2022/news202285.html This information was brought to you by Cision http://news.cision.com The following files are available for download:
SOURCE BioArctic | ||||
Company Codes: Stockholm:BIOAB,ISIN:SE0010323311,RIC:BIOAb.ST,Bloomberg Code:BIOAB@SS |
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