TOKYO and CAMBRIDGE, Mass., May 15, 2024 \u2013 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo
\nNaito, \u201cEisai\u201d) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts,
\nCEO: Christopher A. Viehbacher, \u201cBiogen\u201d) announced today that Eisai has initiated the rolling
\nsubmission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA)
\nfor lecanemab-irmb (U.S. brand name: LEQEMBI\u00ae) subcutaneous autoinjector for weekly maintenance
\ndosing after it was granted Fast Track designation by the FDA. LEQEMBI is indicated for the treatment
\nof Alzheimer\u2019s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of
\ndisease (collectively referred to as early AD).<\/p>\n
The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling
\nof observed data. If approved by the FDA, the LEQEMBI autoinjector could be used to administer
\nLEQEMBI at home or at medical facilities. The injection process requires less time than the IV
\nformulation. As part of the subcutaneous autoinjector 360 mg weekly maintenance regimen under
\nreview, patients who have completed the biweekly IV initiation phase would receive weekly doses that
\nmaintain effective drug concentrations to sustain the clearance of highly toxic protofibrils* which can
\ncontinue to cause neuronal injury even after the amyloid-beta (A\u03b2) plaque has been cleared from the
\nbrain.<\/p>\n
AD is an ongoing neurotoxic process that begins before and continues after plaque deposition. Data
\nsuggest that early and continuing treatment may prolong the benefit even after plaque is cleared from
\nthe brain. This SC autoinjector is easier for patients and their care partners to use, and may reduce the
\nneed for hospital visits and nursing care compared to intravenous (IV) administration. In addition to
\npotentially maintaining the clinical and biomarker benefits, subcutaneous maintenance dosing may be
\nmore convenient for patients and their care partners to continue the treatment.<\/p>\n
LEQEMBI is now approved in the U.S., Japan and China, and applications have been submitted for
\nreview in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia,
\nSaudi Arabia, South Korea, Taiwan, Singapore and Switzerland. Eisai submitted to the FDA a
\nSupplemental Biologics License Application (sBLA) for monthly LEQEMBI intravenous (IV)
\nmaintenance dosing in March 2024.<\/p>\n
Eisai serves as the lead for lecanemab\u2019s development and regulatory submissions globally with both
\ncompanies co-commercializing and co-promoting the product and Eisai having final decision-making
\nauthority.<\/p>\n
* Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be
\nthe most toxic form of A\u03b2, having a primary role in the cognitive decline associated with this progressive,
\ndebilitating condition. Protofibrils cause injury to neurons in the brain, which in turn, can negatively
\nimpact cognitive function via multiple mechanisms, not only increasing the development of insoluble A\u03b2
\nplaques but also increasing direct damage to brain cell membranes and the connections that transmit
\nsignals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may
\nprevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.<\/p>\n","protected":false},"excerpt":{"rendered":"
Eisai and Biogen announced today that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI\u00ae) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA.<\/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":[],"class_list":["post-7855","post","type-post","status-publish","format-standard","hentry","category-news-en"],"_links":{"self":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/7855"}],"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=7855"}],"version-history":[{"count":2,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/7855\/revisions"}],"predecessor-version":[{"id":7857,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/7855\/revisions\/7857"}],"wp:attachment":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/media?parent=7855"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/categories?post=7855"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/tags?post=7855"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}