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Eisai Co., Ltd. and Biogen Inc. (BIIB) 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 drug the first to receive an MA in the EU for targeting an underlying cause of Alzheimer's disease (AD). Adult patients with mild cognitive impairment (MCI) and mild dementia owing to Alzheimer's disease (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes with verified amyloid pathology can benefit from lecanemab medication. The lecanemab MA covers all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway. Lecanemab is the only approved Aβ monoclonal antibody that binds and clears hazardous protofibrils** (soluble Aβ aggregates), while also targeting and decreasing Aβ plaques. Protofibrils, a toxic type of Aβ, can collect in the brain and induce neuronal damage. In Europe, an estimated 15.2 million people suffer from MCI caused by Alzheimer's disease, whereas 6.9 million suffer from AD dementia. 11 AD progresses in stages that worsen with time, and each stage brings unique issues for persons living with the disease and their caregivers. There is a considerable unmet need for innovative therapeutic options that slow the progression of Alzheimer's disease from an early stage and minimize the overall burden on AD patients 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, Eisai is working collaboratively with national reimbursement authorities and healthcare providers to support access for those eligible for lecanemab as soon as possible, aiming to make an impact not only on patients but also on their caregiving families and society in the EU. Haruo Naito 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, 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. Christopher A. Viehbacher Eisai is in charge of lecanemab's global development and regulatory filings, with Eisai and Biogen co-commercializing and co-promoting the product, and Eisai making the final decisions. Eisai and Biogen will co-promote the drug in the EU (excluding the Nordic nations), with Eisai acting as the Master Distributor. Eisai and BioArctic will co-promote the drug in the Nordic countries, with Eisai acting as the Master Distributor. Source: Biogen Last Modified:

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European Union Grants Marketing Approval for Biogen’s Leqembi® an Amyloid-beta (Aβ) Monoclonal Antibody

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