{"id":31962,"date":"2025-04-17T19:47:36","date_gmt":"2025-04-17T11:47:36","guid":{"rendered":"https:\/\/flcube.com\/?p=31962"},"modified":"2025-04-17T19:47:37","modified_gmt":"2025-04-17T11:47:37","slug":"eisai-and-biogen-win-eu-approval-for-leqembi-in-early-alzheimers-disease","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=31962","title":{"rendered":"Eisai and Biogen Win EU Approval for Leqembi in Early Alzheimer’s Disease"},"content":{"rendered":"\n

Eisai Co., Ltd. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB<\/a>) jointly announced that they have received marketing approval from the European Commission (EC) for their amyloid-beta (A\u03b2) monoclonal antibody (mAb) Leqembi (lecanemab). This approval establishes Leqembi as the first therapy in the EU targeting the underlying pathology of Alzheimer’s disease (AD). The drug is now approved to treat adult patients with mild cognitive impairment (MCI) and mild dementia due to AD, including those who are apolipoprotein E \u03b54 (ApoE \u03b54) non-carriers or heterozygotes, with confirmed amyloid pathology across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.<\/p>\n\n\n\n

Mechanism of Action<\/strong>
Leqembi is the world’s only approved A\u03b2 mAb that uniquely addresses dual pathological hallmarks of Alzheimer’s disease. It preferentially neutralizes soluble A\u03b2 protofibrils, which are neurotoxic intermediates implicated in synaptic dysfunction, while also reducing the burden of insoluble A\u03b2 plaques, a key pathological feature of AD progression. This dual action positions Leqembi as a significant advancement in the treatment landscape for early Alzheimer’s disease.<\/p>\n\n\n\n

Market and Patient Impact<\/strong>
The approval of Leqembi in the EU marks a pivotal moment for patients with early AD, offering a new therapeutic option that targets the disease’s underlying pathology. By reducing both soluble and insoluble A\u03b2 species, Leqembi has the potential to slow cognitive decline and improve quality of life for patients in the early stages of the disease.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Eisai Co., Ltd. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) jointly announced that they have…<\/p>\n","protected":false},"author":1,"featured_media":31963,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[351,350,993,15,1151],"class_list":["post-31962","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-biogen","tag-eisai","tag-nasdaq-biib","tag-product-approvals","tag-tyo-4523"],"yoast_head":"\nEisai and Biogen Win EU Approval for Leqembi in Early Alzheimer's Disease - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Eisai Co., Ltd. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) jointly announced that they have received marketing approval from the European Commission (EC) for their amyloid-beta (A\u03b2) monoclonal antibody (mAb) Leqembi (lecanemab). This approval establishes Leqembi as the first therapy in the EU targeting the underlying pathology of Alzheimer's disease (AD). The drug is now approved to treat adult patients with mild cognitive impairment (MCI) and mild dementia due to AD, including those who are apolipoprotein E \u03b54 (ApoE \u03b54) non-carriers or heterozygotes, with confirmed amyloid pathology across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=31962\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Eisai and Biogen Win EU Approval for Leqembi in Early Alzheimer's Disease\" \/>\n<meta property=\"og:description\" content=\"Eisai Co., Ltd. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) jointly announced that they have received marketing approval from the European Commission (EC) for their amyloid-beta (A\u03b2) monoclonal antibody (mAb) Leqembi (lecanemab). This approval establishes Leqembi as the first therapy in the EU targeting the underlying pathology of Alzheimer's disease (AD). 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