Leqembi® (lecanemab) Becomes First Approved Treatment in the EU to Slow Progression of Early Alzheimer’s Disease
Wednesday, April 16, 2025
Eisai Co., Ltd. and Biogen Inc. have announced that the European Commission has authorised the use of Leqembi® (lecanemab), an amyloid-beta (Aβ) monoclonal antibody, for the treatment of early-stage Alzheimer’s disease (AD) in the European Union. This marks the first time a treatment that targets an underlying cause of the disease has received marketing authorisation in the EU.
Lecanemab is approved for adults diagnosed with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease, who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology. The approval extends across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
Unlike other treatments, lecanemab is the only authorised Aβ monoclonal antibody that targets and removes toxic protofibrils—soluble Aβ aggregates—as well as insoluble Aβ plaques. Protofibrils are considered a highly toxic form of amyloid-beta that cause damage to brain cells, contributing significantly to the progression of Alzheimer’s disease.
In Europe, an estimated 15.2 million people live with MCI due to AD, while 6.9 million are affected by Alzheimer’s dementia. The condition worsens over time, and each stage brings new challenges for individuals and their caregivers. There remains a strong demand for new treatments that can slow disease progression from its early stages and help ease the burden on patients, families, and healthcare systems.
With this approval, lecanemab becomes available as the first treatment option in the EU aimed at slowing the cognitive decline seen in early-stage Alzheimer’s. The medicine has already received authorisation in several other regions, including the United States and Japan.
Eisai leads the development and regulatory processes for lecanemab worldwide, while both Eisai and Biogen will jointly promote and commercialise the product. Eisai is responsible for distributing the medicine in the EU as the marketing authorisation holder. In the Nordic countries, Eisai will work in partnership with BioArctic.
Apolipoprotein E plays a role in lipid metabolism and is linked to Alzheimer’s disease. Individuals who carry none or only one copy of the ApoE ε4 gene tend to have a lower risk of experiencing ARIA (amyloid-related imaging abnormalities), a known side effect of lecanemab that may cause brain swelling or bleeding.
Protofibrils are believed to be a leading cause of damage in the brain linked to Alzheimer’s disease. By reducing protofibrils, lecanemab may help slow cognitive decline and protect neurons and their ability to transmit signals, potentially offering significant benefits for those in the early stages of the disease.
Source: globenewswire.com
