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Lecanemab (Leqembi®) Becomes First EU-Approved Disease-Modifying Therapy to Slow Progression of Early Alzheimer’s Disease

Apr 16, 2025 13:50 CST Updated 13:50
Eisai

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Biogen

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  • In the European Union (EU), lecanemab is indicated for the treatment of adult patients with early Alzheimer's disease (AD) who are clinically diagnosed with mild cognitive impairment or mild dementia, are non-carriers or heterozygous for apolipoprotein E ε4 (ApoE ε4*), and have confirmed amyloid-beta pathology.
  • Lecanemab is the first drug approved in the EU for treating eligible patients with early Alzheimer's disease (early AD) that targets the underlying cause of the disease.

Eisai and Biogen Jointly Announce that the European Commission (EC) Has Approved the Marketing Authorization (MA) for Leqembi® (Lecanemab), a β-Amyloid Monoclonal Antibody, in the European Union (EU). This Makes the Drug the First Treatment Targeting the Underlying Cause of AD to be Approved for Marketing in the EU.1，2。

The indication for Lecanemab is: for the treatment of adult patients with early Alzheimer's disease (AD) clinically diagnosed with mild cognitive impairment and mild dementia, who are non-carriers or heterozygous for apolipoprotein E ε4 (ApoE ε4*), and confirmed to have β-amyloid pathology.1The marketing authorization for Lecanemab applies to all 27 member states of the EU, as well as Iceland, Liechtenstein, and Norway.

Lecanemab is the only approved β-amyloid monoclonal antibody. Lecanemab can selectively bind and clear toxic fibrils (soluble Aβ aggregates) while also targeting and reducing Aβ plaques (insoluble Aβ aggregates).1,2,4-7. Fibrils are a key toxic form of Aβ that accumulate in the brain and cause neuronal damage.4-10

Currently, in Europe, mild cognitive impairment and Alzheimer's dementia caused by Alzheimer's disease affect approximately 15.2 million people and 6.9 million people, respectively.11Alzheimer's disease progresses in stages, with the condition gradually worsening over time. Each stage of the disease presents different challenges for patients and their caregivers. There is a significant unmet need for new treatments that can slow the progression of Alzheimer's from its early stages and reduce the overall burden the disease places on patients and society.

Eisai CEO Haruo Naito stated: "The EU approval of Leqembi as the first treatment option capable of slowing the progression of early Alzheimer's disease fills us with immense pride. With nearly 40 years of dedication and expertise in the field of dementia, achieving this significant milestone underscores our commitment. We are steadfast in our mission to create a better future for those affected by this disease globally, and this solution marks an essential step forward. Eisai is actively collaborating with healthcare insurance and service providers across nations to promptly support patients eligible for Leqembi treatment. Our goal extends beyond benefiting patients; we aim to contribute to caregivers, patient families, and society across the EU."

Biogen President and CEO Christopher A. Viehbacher stated, "The European Commission's approval of lecanemab marks the thirteenth major region to approve this important drug. Previously, it has benefited thousands of patients in the United States, Japan, and other parts of the world. Lecanemab is the first treatment to demonstrate a correlation between the reduction of Aβ plaques in the brain and a slowing of cognitive decline in patients with early-stage disease. This represents a landmark advancement in the field over the past 20 years, during which there has been little to no innovation."

Eisai is leading the global development and registration application of lecanemab, while the product is jointly commercialized and promoted by Eisai and Biogen. Among them, Eisai has the final decision-making power. In the EU (excluding Nordic countries), Eisai and Biogen will jointly promote the drug, with Eisai being the marketing authorization holder responsible for product distribution. In the Nordic countries, Eisai and BioArctic will jointly promote the drug, also with Eisai as the marketing authorization holder responsible for product distribution.

 

References

  1. European Medicines Agency Summary of Product Characteristics （SmPC）
  2. van Dyck, C.H., et al. Lecanemab in Early Alzheimer’s Disease. New England Journal of Medicine. 2023;388:9-21. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948.
  3. European Medicines Agency. Authorisation of medicines. Available at: https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines. Last accessed: April 2025.
  4. Johannesson, M., et al. Lecanemab demonstrates highly selective binding to Aβ protofibrils isolated from Alzheimer’s disease brains. Molecular and Cellular Neuroscience. 2024;130:103949. https://doi.org/10.1016/j.mcn.2024.103949.
  5. Sehlin, D., et al. Large aggregates are the major soluble Aβ species in AD brain fractionated with density gradient ultracentrifugation. PLoS One. 2012;7(2):e32014. https://doi.org/10.1371/journal.pone.0032014.
  6. Söderberg, L., et al. Lecanemab, Aducanumab, and Gantenerumab — Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer’s Disease. Neurotherapeutics. 2022;20(1):195-206. https://doi.org/10.1007/s13311-022-01308-6.
  7. Selkoe, D. Does the Current Evidence for Lecanemab Mechanism Support a Rationale for Continued Lecanemab Dosing? Presented at Alzheimer’s Association International Conference, 2024.
  8. Amin, L., Harris, D.A. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nature Communications. 2021;12:3451. doi:10.1038/s41467-021-23507-z.
  9. Ono, K., Tsuji, M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer’s Disease. International Journal of Molecular Sciences. 2020;21(3):952. https://doi.org/10.3390/ijms21030952
  10. Noguchi‐Shinohara, M. and Shuta, K, et al. Lecanemab-Associated Amyloid-β Protofibril in Cerebrospinal Fluid Correlates with Biomarkers of Neurodegeneration in Alzheimer’s Disease. Annals of Neurology. 2025;in press. https://doi.org/10.1002/ana.27175.
  11. Gustavsson, A., et al. Global estimates on the number of persons across the Alzheimer’s disease continuum.Alzheimer’s & Dementia. 2023;19:658-670.https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12694.

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