TOKYO and CAMBRIDGE, Mass., February 28, 2023 \u2013 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI\u2122), an investigational anti-amyloid beta (A\u03b2) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. The Priority Review and Approval Procedure was implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this Procedure, the assessment period is expected to be shortened.<\/p>\n
In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022. Eisai initially submitted a package that includes data from the Phase II clinical trial (Study 201) and the top-line data of the large global Phase III Clarity AD study in mild cognitive impairment (MCI) due to Alzheimer\u2019s disease (AD) and mild AD (collectively known as early AD) with confirmed A\u03b2 accumulation in the brain. Eisai will submit additional data including full data of the Clarity AD study, as directed by the NMPA.<\/p>\n
Lecanemab selectively binds and eliminates soluble, toxic A\u03b2 aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer\u2019s Disease (CTAD) conference, and simultaneously published in the New England Journal of Medicine<\/i>, a peer-reviewed medical journal.<\/p>\n
In the U.S., lecanemab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023,\u00a0 which was accepted on January 26, 2023. In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023, and\u00a0 Priority Review was designated by the Ministry of Health, Labour and Welfare (MHLW)\u00a0 on January 26, 2023.<\/p>\n
Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.<\/p>\n
<\/p>\n
| Contacts<\/td>\n<\/tr>\n | |
| MEDIA CONTACT:<\/span><\/p>\n Eisai Co., Ltd.<\/span><\/p>\n Public Relations Department<\/span><\/p>\n TEL: +81-(0)3-3817-5120<\/span><\/p>\n <\/p>\n <\/p>\n INVESTOR CONTACT:<\/span><\/p>\n Eisai Co., Ltd.<\/span><\/p>\n Investor Relations Department<\/span><\/p>\n TEL: +81-(0)3-3817-5122<\/span><\/td>\n | MEDIA CONTACT:<\/span><\/p>\n Biogen Inc.<\/span><\/p>\n Natacha Gassenbach<\/span><\/p>\n + 1-857-777-6573<\/span><\/p>\n public.affairs@biogen.com<\/span><\/p>\n <\/p>\n INVESTOR CONTACT:<\/span><\/p>\n Biogen Inc.<\/span><\/p>\n Mike Hencke<\/span><\/p>\n + 1-781-464-2442<\/span><\/p>\n IR@biogen.com<\/u><\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"excerpt":{"rendered":" TOKYO and CAMBRIDGE, Mass., February 28, 2023 \u2013 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI\u2122), an investigational anti-amyloid beta (A\u03b2) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. The Priority Review and Approval Procedure was implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this Procedure, the assessment period is expected to be shortened.<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28],"tags":[],"class_list":["post-6424","post","type-post","status-publish","format-standard","hentry","category-news-en"],"_links":{"self":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/6424"}],"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\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/comments?post=6424"}],"version-history":[{"count":5,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/6424\/revisions"}],"predecessor-version":[{"id":6441,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/6424\/revisions\/6441"}],"wp:attachment":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/media?parent=6424"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/categories?post=6424"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/tags?post=6424"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}} |