{"id":23011,"date":"2023-01-09T22:56:00","date_gmt":"2023-01-09T14:56:00","guid":{"rendered":"https:\/\/flcube.com\/?p=23011"},"modified":"2025-01-25T23:01:07","modified_gmt":"2025-01-25T15:01:07","slug":"eisai-ceo-outlines-ambitions-for-alzheimers-drug-leqembi-after-fda-approval","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=23011","title":{"rendered":"Eisai CEO Outlines Ambitions for Alzheimer\u2019s Drug Leqembi After FDA Approval"},"content":{"rendered":"\n

Following US FDA approval for Japan-based Eisai Co., Ltd (TYO: 4523<\/a>) and Biogen Inc\u2019s (NASDAQ: BIIB<\/a>) novel Alzheimer\u2019s therapy Leqembi (lecanemab), Eisai CEO Haruo Naito gave an interview with Nikkei setting out his ambitions for the drug. According to Naito, the US market eligible to use Leqembi annually currently stands at around 100,000, while globally, once markets such as India and China are added by 2030, that number is put at 2.5 million.<\/p>\n\n\n\n

FDA Approval and Clinical Data<\/strong>
The US FDA issued a fast-track approval for Leqembi in 100 mg\/mL injection form on Friday last week based on Phase IIb data only, indicated as a treatment for mild cognitive impairment or dementia. Recently published Phase III data show that lecanemab can produce a 27% slowdown in cognitive decline in early-stage Alzheimer\u2019s patients. The drug\u2019s recommended dosage is 10 mg\/kg administered intravenously once every two weeks.<\/p>\n\n\n\n

Market and Pricing<\/strong>
Leqembi is Eisai\/Biogen\u2019s second major Alzheimer\u2019s antibody to win approval in the US in a matter of months, following the also amyloid beta-targeted Aduhelm (aducanumab) in June 2021. As with Aduhelm, the approval is not without controversy. Leqembi use is also associated with significant side effects including amyloid-related imaging abnormalities (ARIAs) \u2013 swelling or bleeding in the brain \u2013 affecting over 20% of patients in one study compared to just over 9% in placebo.<\/p>\n\n\n\n

Eisai\/Biogen expects Leqembi to be made available to US patients by January 23, priced at USD 26,500 for one year of treatment, or around half the price of Aduhelm. Notably, the drug was filed for approval in China by Eisai in late December 2022, while filings in the EU and Japan have yet to be formally made.<\/p>\n\n\n\n

Future Outlook<\/strong>
The approval of Leqembi by the FDA and Eisai\u2019s ambitious plans for global expansion highlight the ongoing efforts to address the significant unmet needs in Alzheimer\u2019s disease treatment. With demonstrated efficacy in slowing cognitive decline and a more accessible pricing strategy, Leqembi is poised to make a meaningful impact on patient outcomes. Eisai\u2019s strategic focus on expanding into key markets such as China and India underscores its commitment to making this innovative therapy available to patients worldwide.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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Following US FDA approval for Japan-based Eisai Co., Ltd (TYO: 4523) and Biogen Inc\u2019s (NASDAQ:…<\/p>\n","protected":false},"author":1,"featured_media":0,"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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[351,87,350,993,15,1151],"class_list":["post-23011","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-biogen","tag-chronic-disease","tag-eisai","tag-nasdaq-biib","tag-product-approvals","tag-tyo-4523"],"yoast_head":"\nEisai CEO Outlines Ambitions for Alzheimer\u2019s Drug Leqembi After FDA Approval - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Following US FDA approval for Japan-based Eisai Co., Ltd (TYO: 4523) and Biogen Inc\u2019s (NASDAQ: BIIB) novel Alzheimer\u2019s therapy Leqembi (lecanemab), Eisai CEO Haruo Naito gave an interview with Nikkei setting out his ambitions for the drug. 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