Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 28 |
| INN | Lecanemab |
| Status | Approved |
| Drug code(s) | BAN2401 |
| Brand name | Leqembi, 乐意保® |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Amyloid beta (protofibrils) |
| Indications of clinical studies | Alzheimer's Disease |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Approved US, Japan, China, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 01, 2010 |
| Start of Phase 2 | December 15, 2012 |
| Start of Phase 3 | March 15, 2019 |
| Date BLA/NDA submitted to FDA | December 14, 2021 |
| Year of first approval (global) | 2023 |
| Date of first US approval | January 06, 2023 |
| INN, US product name | Lecanemab, lecanemab-irmb |
| US or EU approved indications | Treatment of Alzheimer’s disease |
| Company | BioArctic Neuroscience |
| Licensee/Partner | Eisai, Biogen |
| Comments about company or candidate | Aug 22, 2024: Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain announced. Jan 2024: LEQEMBI®” (brand name in China: “乐意保®”, generic name: lecanemab-irmb) has been approved in China as a treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. July 6, 2023: U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Mar 5 2023: FDA has accepted Eisai’s supplemental Biologics License Application (sBLA) for LEQEMBI™ (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval. The LEQEMBI application has been granted Priority Review, with a PDUFA action date of July 6, 2023. The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting. Jan 2023: EMA accepts MAA submission. Sep 2022: Eisai Co., Ltd. and Biogen Inc. announced positive topline results from Eisai’s large global Phase 3 confirmatory Clarity AD clinical trial of lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results. Eisai will discuss this data with regulatory authorities in the U.S., Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of Eisai’s FY2022, which ends March 31, 2023. July 2022: BLA granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023. The readout of the primary endpoint data of Clarity AD will occur in the fall of 2022. The FDA has agreed that the results of Clarity AD when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. May 10, 2022: Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401) for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. As part of the completed rolling submission, Eisai has requested Priority Review. March 2022: Eisai initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data of lecanemab under the prior assessment consultation system in Japan in March 2022. Sep 28, 2021: Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401) June 2021: Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer’s disease NCT04468659 AHEAD 3-45 Study Phase 3 started on July 13, 2020. NCT03887455 Phase 3 study in Subjects With Early Alzheimer's Disease recruiting as of March 2019. Feb 2019: BioArctic announced that Eisai stated at their Q3 FY2018 Financial Results Meeting on February 4, 2019, that a single Phase III confirmatory study of BAN2401 in early Alzheimer´s disease patients is under preparation and planned to be initiated within Eisai’s FY2018 i.e. the first quarter 2019. July 2018: positive topline results from the Phase 2b study with BAN2401 (ClinicalTrials.gov identifier NCT01767311), an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer’s disease, were announced. The study achieved statistical significance on key efficacy endpoints at 18 months on slowing progression in Alzheimer’s Disease Composite Score (ADCOMS) and on reduction of amyloid accumulated in the brain as measured by using amyloid-PET (Positron Emission Tomography). Initial Independent Data Monitoring Analysis indicated that BAN2401 did not cross a threshold for either success or futility at 12 months. NCT01767311 Phase 2 study active not recruiting as of July 2017 |
| Full address of company | Warfvinges väg 35, SE-112 51 Stockholm, Sweden Europe Sweden https://www.bioarctic.se/en/contact-us/ |
mAb158 is a murine monoclonal antibody that was raised to target protofibrils, and BAN2401 is the humanized IgG1 monoclonal version that selectively binds to Aβ protofibrils. In vitro studies demonstrated that the binding characteristics are essentially indistinguishable from mAb158. BAN2401 has at least a 1000-fold higher selectivity for protofibrils compared to monomers and 10-15 times better binding to protofibrils than to fibrils (Alzheimers Res Ther. 2016; 8: 14). A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer's Disease with Lecanemab, an Anti-Aß Protofibril Antibody, published in Alzheimer's Research and Therapy in April 2021.
| Anticipated events | Regulatory review EU - anticipate approval |
| Factor(s) contributing to discontinuation | None |