▎WuXiEdited by Kant Content Team

Eisai and Biogen recently announced,The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has once again confirmed its positive opinion on the jointly developed Alzheimer's disease (AD) therapy Leqembi (lecanemab), recommending it for the treatment of adult patients with mild cognitive impairment and mild dementia (early Alzheimer's disease) caused by confirmed Alzheimer’s disease., these patients are carriers of the apolipoprotein E ε4 allele (APOEε4) non-carriers or heterozygotes, with definitive amyloid pathology. Following the positive opinion from the CHMP, the European Commission (EC), after reviewing supplementary information, will resume the decision-making process for the marketing authorization of Leqembi.

In January 2025, as part of the decision-making process, the EC requested the CHMP to review new information on the safety of Leqembi that emerged after the positive opinion was adopted in November 2024. The CHMP will assess whether an update to the opinion is necessary and consider whether the wording of risk minimization measures in the opinion is sufficiently clear.After reviewing the supplementary information, the CHMP concluded that no adjustment to its positive opinion on Leqembi was necessary.

Leqembi can specifically bind to soluble oligomers of β-amyloid protein.In the brains of AD patients, elevated levels of β-amyloid lead to their aggregation from monomers into dimers and soluble oligomers, which eventually further accumulate into amyloid plaques in the brain. Scientific research shows that soluble oligomers of β-amyloid exhibit stronger cytotoxicity than monomers. Leqembi neutralizes and clears these toxic soluble oligomers by binding to them.

Leqembi has already been approved in countries and regions such as the United States, Japan, China, South Korea, Israel, the United Arab Emirates, and the United Kingdom. In January this year, its maintenance treatment regimen of once every four weeks via intravenous infusion (IV) was approved.FDA Approval, for the treatment of Alzheimer's disease patients in the mild cognitive impairment or mild dementia stage. After an initial treatment phase of once every two weeks for 18 months, patients may be considered for a maintenance treatment regimen of 10 mg/kg once every four weeks, or they can continue receiving treatment at 10 mg/kg once every two weeks.

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