Leqembi (lecanemab) is the first medicine that slows progression of early Alzheimer's disease to be authorized in the EU

Eisai Co., Ltd. and Biogen Inc. have announced that the European Commission (EC) has granted the amyloid-beta (Aβ) monoclonal antibody Leqembi^® (lecanemab) Marketing Authorization (MA) in the European Union (EU). This makes the medicine the first therapy that targets an underlying cause of Alzheimer’s disease (AD) to be granted an MA in the EU.

Lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD (early AD) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology.1 The lecanemab MA applies to all 27 EU Member States as well as Iceland, Liechtenstein, and Norway.

Lecanemab is the only approved Aβ monoclonal antibody that preferentially binds and clears toxic protofibrils (soluble Aβ aggregates), in addition to targeting and reducing Aβ plaques (insoluble Aβ aggregates).Protofibrils are a key toxic form of Aβ that accumulate in the brain and cause neuronal injury.

MCI due to AD and AD dementia currently affects an estimated 15.2 million and 6.9 million people in Europe, respectively. AD progresses in stages that increase in severity over time, and each stage of the disease presents different challenges for those living with AD and their care partners. There is a significant unmet need for new treatment options that slow down the progression of AD from its early stage and reduce the overall burden on people affected by AD and society.

“Today’s decision makes lecanemab the first treatment option in the EU that can slow the progression of early Alzheimer's disease. We are proud that our about 40-year heritage in dementia has led to this important milestone, as we aim to be part of the solution for a better future for those impacted by this disease globally,” said Haruo Naito, Chief Executive Officer at Eisai.

“The approval of lecanemab by the European Commission marks the thirteenth approval of this important medicine, which has already benefitted thousands of patients in the United States, Japan and other regions of the world,” said Christopher A. Viehbacher, President and Chief Executive Officer at Biogen. “Lecanemab is the first treatment which showed that the reduction of the Aβ plaques in the brain is associated with the slowing of cognitive decline in patients at the early stage of the disease. This is a landmark advancement in a field where there has been no or little innovation in the past 20 years.”

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