On 14th November 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency announced their positive opinion on the marketing authorisation of lecanemab (monoclonal anti-beta-amyloid antibody; trade name: Leqembi from Eisai and Biogen) in the European Union for the treatment of early Alzheimer’s disease in Europe.
In 2023, the drug had already received approval by the US Food and Drug Administration (FDA). Subsequently, approval had also been granted in other countries around the world.
According to the recommendation of the CHMP, Leqembi is intended for the treatment of adult patients diagnosed with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia), however excluding those patients who are homozygous carriers of the ɛ4 allele of the apolipoprotein E (APOE) gene.
This decision is based on the results of clinical studies revealing that patients carrying two copies of APOE ɛ4 show the highest risk among all APOE genotypes for developing potentially life-threating side effects under anti-amyloid-beta therapy (Leqembi recommended for treatment of early Alzheimer’s disease | European Medicines Agency (EMA)).
These are known under the term ARIA (amyloid-related imaging abnormalities), referring to edema or microbleedings in the brain (Filippi M et al, (2022)).
APOE genotyping prior to the start of the anti-amyloid (beta) therapy in Alzheimer’s disease has therefore become crucial to assess a patient’s risk for side effects: Patients with only one or no copy of the ɛ4 allele can be treated with Leqembi, according to the marketing authorization in the European Union, patients with 2 copies of the ɛ4 allele are excluded from therapy due to the increased risk of ARIA.
Learn more about the significance of APOE genotyping in our whitepaper or the IVDR-compliant PCR-based EURORealTime APOE for precise determination of the APOE genotype.
The EURORealTime APOE was developed in parallel to the research on active substances and in close cooperation with the pharmaceutical industry.
It is also worth noting that we offer additional ELISA and chemiluminescence immunoassays for the determination of the biomarkers amyloid beta, total tau and pTau to support Alzheimer’s diagnostics.
Like this, EUROIMMUN provides a convenient package to support Alzheimer’s diagnostics: From supporting early recognition of the disease to the risk assessment prior to the start of therapy.
Learn more on our website: APOE | EUROIMMUN Alzheimer’s disease | EUROIMMUN