Leqembi Makes History as First EU-Approved Drug to Target Root Cause of Alzheimer’s Disease

Eisai Co., Ltd. and Biogen Inc. announced that the European Commission (EC) has granted Marketing Authorization (MA) in the European Union (EU) for Leqembi (lecanemab), an amyloid-beta (Aβ) monoclonal antibody. Leqembi is the first therapy in the EU approved to target an underlying cause of Alzheimer’s disease.

Leqembi Approved Across 30 European Countries for Early Alzheimer’s Treatment in Eligible Adults

Eisai and Biogen’s Leqembi treats adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes with confirmed amyloid pathology. The Marketing Authorization applies across all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway.

Leqembi is the only approved amyloid-beta (Aβ) monoclonal antibody that actively binds to and clears toxic protofibrils, soluble Aβ aggregates, and targets and reduces insoluble Aβ plaques. Protofibrils represent a key toxic form of Aβ that accumulates in the brain and contributes to neuronal damage.

Haruo Naito, Chief Executive Officer at Eisai, said, “Today’s decision makes lecanemab the first treatment option in the EU that slows the progression of early Alzheimer’s disease. We take pride in our nearly 40-year heritage in dementia, which 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.”

Alzheimer’s Cases in Europe Projected to Reach 14 Million with Costs Exceeding €250 Billion by 2030

MCI due to AD and AD dementia currently affect an estimated 15.2 million and 6.9 million people in Europe, respectively. Alzheimer’s disease progresses in stages of increasing severity, with each stage posing distinct challenges for individuals and their care partners. There remains a significant unmet need for treatment options that can slow disease progression in its early stages and help reduce the overall burden on patients, caregivers, and society.

In July 2024, Eisai and Biogen marked a significant milestone with the approval of LEQEMBI in Hong Kong. The decision was based on results from the global Phase 3 Clarity AD study, which demonstrated that LEQEMBI met all primary and secondary endpoints with statistically significant results. The treatment slowed cognitive and functional decline, reduced brain amyloid plaque levels by 30%, and improved daily living activities by 20%. Patients also showed a 25% improvement in cognitive performance.

An estimated 7 million people in Europe are currently living with Alzheimer’s disease. As the population continues to age, the number will double to 14 million by 2030, turning Alzheimer’s into a growing global public health challenge. The societal and economic impact of dementia in Europe is also substantial, with costs projected to exceed EUR 250 billion by 2030. 

Christopher A. Viehbacher, President and Chief Executive Officer at Biogen, said, “Lecanemab is the first treatment to demonstrate that reducing Aβ plaques in the brain slows cognitive decline in patients at the early stage of the disease. This advancement marks a landmark achievement in a field that has seen little or no innovation in the past 20 years.”

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Denisse Sandoval