锘縶"id":7559,"date":"2023-12-13T10:51:50","date_gmt":"2023-12-13T02:51:50","guid":{"rendered":"https:\/\/www.eisai.com.cn\/?p=7559"},"modified":"2023-12-27T11:15:10","modified_gmt":"2023-12-27T03:15:10","slug":"leqembi-intravenous-infusion-lecanemab-for-the-treatment-of-alzheimers-disease-to-be-launched-in-japan-on-december-20","status":"publish","type":"post","link":"https:\/\/www.eisai.com.cn\/en\/2023\/12\/13\/leqembi-intravenous-infusion-lecanemab-for-the-treatment-of-alzheimers-disease-to-be-launched-in-japan-on-december-20\/","title":{"rendered":"\u201cLEQEMBI\u00ae Intravenous Infusion\u201d (Lecanemab) for the Treatment of Alzheimer\u2019s Disease to be Launched in Japan on December 20"},"content":{"rendered":"<p style=\"text-align: left;\"><b>TOKYO and CAMBRIDGE, Mass., December 13, 2023\u00a0<\/b>\u2013<b>\u00a0<\/b>Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, \u201cEisai\u201d) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, \u201cBiogen\u201d) announced today that humanized anti- soluble aggregated amyloid-beta (A\u03b2) monoclonal antibody \u201cLEQEMBI<sup>\u00ae<\/sup> Intravenous Infusion\u201d (200mg, 500mg, lecanemab) will be launched in Japan on December 20, following its scheduled inclusion in the price listing on the Japan National Health Insurance (NHI) Drug Price List.<\/p>\n<p>LEQEMBI received manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer\u2019s disease (AD) in Japan on September 25, 2023. In addition to inclusion in Japan\u2019s NHI Drug Price List, the product\u2019s Optimal Clinical Use Guidelines were agreed at a general meeting of the Central Social Insurance Medical Council, an advisory body of the Japanese Ministry of Heath, Labour and Welfare, held today. The launch in Japan marks the second country to have LEQEMBI on the market, following the U.S.<br \/>\nIn Japan, Eisai and Biogen Japan will co-promote LEQEMBI, with Eisai distributing the product as the Marketing Authorization Holder.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-7555 aligncenter\" src=\"https:\/\/www.eisai.com.cn\/wordpress\/wp-content\/uploads\/2023\/12\/202374-01.jpg\" alt=\"\" width=\"700\" height=\"466\" \/><\/p>\n<p>LEQEMBI selectively binds to soluble amyloid-beta (A\u03b2) aggregates (protofibrils), as well as insoluble A\u03b2 aggregates (fibrils) which are a major component of A\u03b2 plaques, thereby reducing both A\u03b2 protofibrils and A\u03b2 plaques in the brain. LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.<\/p>\n<p>\u201cI am keenly aware of the weight of our responsibility moving forward as we launch LEQEMBI, the world first anti-amyloid Alzheimer&#8217;s disease treatment shown to slow the progress of the disease, in Japan, where Eisai\u2019s value creation has started\u201d said Haruo Naito, Chief Executive Officer at Eisai. \u201cThe establishment of an optimal and fast Alzheimer&#8217;s disease diagnosis and treatment pathway for patients is a top priority, and close collaboration among the government, dementia specialists, primary care physicians, radiologists, pharmacists, nurses, clinical psychologists, radiology staff, medical office personnel, and caregivers is essential for this purpose. In consideration of the importance of Alzheimer\u2019s disease in Japan, we believe it is imperative that such pathways be established. We are committed to taking this first step towards changing the future of Alzheimer\u2019s disease together with our stakeholders.\u201d<\/p>\n<p>\u201cThe availability of LEQEMBI opens a new era in the treatment of Alzheimer\u2019s disease potentially giving patients and their families additional valuable time together and further positions Japan as a leader in caring for an elderly population,\u201d said Christopher A. Viehbacher, President and Chief Executive Officer of Biogen \u201cWe will work alongside Eisai to engage the medical community and support the patient journey, especially early diagnosis, as mounting evidence suggests early intervention may provide greater impact on disease progression.\u201d<\/p>\n<p>Eisai will conduct a post-marketing special use results survey in all patients who are administered LEQEMBI (all-case surveillance) until data from a certain number of patients are accumulated, in accordance with an approval condition imposed by the Ministry of Health, Labour and Welfare. In addition, the appropriate use of LEQEMBI will be promoted in accordance with the package insert and the Optimal Clinical Use Guidelines, and training materials will be provided for healthcare professionals to assist with the management and monitoring of amyloid-related imaging abnormalities (ARIA).<\/p>\n<p>Eisai and Biogen are committed to promoting the early detection and diagnosis of AD towards its early treatment, and will do their utmost to deliver LEQEMBI the people with early AD and realize a Dementia-Inclusive Society.<\/p>\n<p>&nbsp;<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-7556\" src=\"https:\/\/www.eisai.com.cn\/wordpress\/wp-content\/uploads\/2023\/12\/11\u4f01\u4e1a\u5fae\u4fe1\u622a\u56fe_17036454648565.png\" alt=\"\" width=\"644\" height=\"769\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>TOKYO and CAMBRIDGE, Mass., December 13, 2023\u00a0\u2013\u00a0Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, \u201cEisai\u201d) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, \u201cBiogen\u201d) announced today that humanized anti- soluble aggregated amyloid-beta (A\u03b2) monoclonal antibody \u201cLEQEMBI\u00ae\u00a0Intravenous Infusion\u201d (200 mg, 500mg, lecanemab) will be launched in Japan on December 20, following its scheduled inclusion in the price listing on the Japan National Health Insurance (NHI) Drug Price List.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28],"tags":[],"_links":{"self":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/7559"}],"collection":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/comments?post=7559"}],"version-history":[{"count":4,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/7559\/revisions"}],"predecessor-version":[{"id":7566,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/7559\/revisions\/7566"}],"wp:attachment":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/media?parent=7559"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/categories?post=7559"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/tags?post=7559"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}