TOKYO and CAMBRIDGE, Mass.,<\/span> January<\/span> 7<\/span>, 2023<\/span> \u2013<\/span> Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo <\/span>Naito,<\/span> \u201c<\/span>Eisai<\/span>\u201d<\/span>) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: <\/span>Christopher A. Viehbacher,<\/span> \u201c<\/span>Biogen<\/span>\u201d<\/span>) announced today that u<\/span>nder the Accelerated Approval Pathway the <\/span>U.S. Food and Drug Administration (FDA) has approved lecanemab<\/span>–<\/span>irmb (Brand Name in the U.S.: <\/span>LEQEMBI\u2122) 100 mg\/mL injection for intravenous use,<\/span> a humanized immunoglobulin gamma 1 (IgG1) <\/span>monoclonal antibody directed<\/span> against aggregated soluble<\/span> (\u201cprotofibril\u201d)<\/span>*<\/span> and insoluble forms of amyloid beta <\/span>(A\u03b2)<\/span> for the treatment of Alzheimer\u2019s disease<\/span> (AD)<\/span>. The approval is based on Phase 2 data that <\/span>demonstrated that LEQEMBI reduced the accumulation of A\u03b2 plaque in the<\/span> brain, a defining feature of AD. <\/span>Using the recently published data from the large global confirmatory Phase 3 clinical trial, Clarity AD, Eisai <\/span>will work quickly to file a Supplemental Biologics License Application (sBLA) to the FDA for approval under <\/span>the<\/span> traditional pathway.<\/span><\/p>\n

INDICATION<\/span><\/strong>
LEQEMBI is indicated for the treatment of Alzheimer\u2019s disease. Treatment with LEQEMBI should be <\/span>initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in <\/span>which treatment was i<\/span>nitiated in clinical trials.<\/span> There are no safety or effectiveness data on initiating <\/span>treatment at earlier or later stages of the disease than were studied.<\/span> This indication is approved under <\/span>accelerated approval based on reduction in amyloid beta plaques ob<\/span>served in patients treated with <\/span>LEQEMBI.<\/span> Continued approval for this indication may be contingent upon verification of clinical benefit in a <\/span>confirmatory trial.<\/span><\/p>\n

DOSAGE AND ADMINISTRATION<\/span> (Patient Selection, Dosing Instructions, Monitoring and Dosing <\/span>Interruption for ARIA)<\/span><\/strong>
The recommended dosage of LEQEMBI is 10 mg\/kg administered intravenously once every two weeks to <\/span>eligible patients with confirmed presence of A\u03b2 pathology prior to initi<\/span>ating treatment. Enhanced clinical <\/span>vigilance for amyloid<\/span>–<\/span>related imaging abnormalities (ARIA) is recommended during the first 14 weeks of <\/span>treatment with LEQEMBI. Baseline, recent (within one year) brain MRI prior to initiating treatment with <\/span>LEQEMBI and pe<\/span>riodic monitoring with MRI prior to the 5th, 7th, and 14th infusions<\/span> should be<\/span> o<\/span>btained<\/span>.<\/span><\/p>\n

ADVERSE REACTIONS<\/span><\/strong>
The safety of LEQEMBI has been evaluated in 763 patients who received at least one dose of LEQEMBI <\/span>in Study 201<\/span>.<\/span> The most common adverse reactions reported in at least 5% of patients treated with LEQEMBI <\/span>10 mg\/kg biweekly (N=161) and at<\/span> least 2%<\/span> higher<\/span> incidence than patients on placebo (N=245) were <\/span>infusion<\/span>–<\/span>related reactions (LEQEMBI 20%; placebo 3%), headache (LEQE<\/span>MBI 14%; placebo 10%), ARIA<\/span>E (LEQEMBI 10%; placebo 1%), cough (LEQEMBI, 9%; placebo, 5%)<\/span> and<\/span> diarrhea (LEQEMBI, 8%; <\/span>placebo, 5%). The most common adverse reaction leading to discontinuation of LEQEMBI was infusion<\/span>related reactions that led to discontinua<\/span>tion in 2% (4\/161) of patients treated with LEQEMBI compared to <\/span>1<\/span>% (2\/245) of patients on placebo.<\/span><\/p>\n

\u201cThe FDA\u2019s approval of LEQEMBI under the Accelerated Approval pathway is a<\/span>n important<\/span> milestone in <\/span>Eisai\u2019s four decades of research in Alzheimer\u2019s disease and reflects our continued commitment to <\/span>alleviating the burden of Alzheimer\u2019s disease for patients and their families. Eisai has made great efforts to <\/span>understand the reality of the chal<\/span>lenges and concerns facing patients and their families who are living in <\/span>the various stages of Alzheimer\u2019s disease, and we are incredibly pleased to offer LEQEMBI as a new <\/span>treatment option to help with the tremendous unmet needs of this community,\u201d said Ha<\/span>ruo Naito, Chief <\/span>Executive Officer at Eisai Co., Ltd. \u201cThe challenges of Alzheimer\u2019s disease reach beyond medical <\/span>implications for patients and considerations for their families, but also impact society as a whole through <\/span>reduced productivity, elevated soc<\/span>ial costs and anxiety. Upon receiving this Accelerated Approval, we will <\/span>focus on providing important information on proper usage of LEQEMBI to healthcare professional<\/span>s<\/span>. Eisai <\/span>will also engage with various payers to provide access to LEQEMBI, offer<\/span> a<\/span> patie<\/span>nt support program, and<\/span>
will do its utmost to complete submission for traditional approval as soon as possible to serve more people <\/span>living with early Alzheimer\u2019s disease.\u201d<\/span><\/p>\n

\u201cThe approval of LEQEMBI provides new hope to patients with Alzheimer\u2019s<\/span> d<\/span>isease. Pa<\/span>tients at an early <\/span>stage of the disease and their caregivers can now consider a new treatment option with their doctors. Our <\/span>focus now is on the path forward, working alongside Eisai with the goal of making LEQEMBI available to <\/span>patients who may benefit fro<\/span>m this treatment as soon as possible,\u201d said<\/span> Christopher A. Viehbacher, <\/span>President and Chief Executive Officer of Biogen<\/span>. \u201cThis approval is also<\/span> a<\/span> recognition of the many scientists <\/span>and doctors who have, over many years, patiently and persistently worked to<\/span> find a treatment for this highly <\/span>complex disease. Eisai and Biogen have collaborated for nearly a decade<\/span> to advance research<\/span> to improve <\/span>the lives of those suffering from Alzheimer\u2019s, and we know that this commitment must and will continue in <\/span>the fight agai<\/span>nst<\/span> Alzheimer’s disease<\/span>.\u201d<\/span><\/p>\n

Media Contacts:<\/span><\/strong>
Eisai Co., Ltd.<\/span>
Public Relations <\/span>Department<\/span>
TEL: +81 (0)3<\/span>–<\/span>3817<\/span>–<\/span>5120<\/span><\/p>\n

Eisai Inc. (U.S.)<\/span>
Libby Holman<\/span>
+ 1<\/span>–<\/span>201<\/span>–<\/span>753<\/span>–<\/span>1945<\/span>
Libby_Holman@eisai.com<\/span><\/p>\n

Eisai Europe, Ltd.
\n(UK, Europe, Australia, New Zealand and Russia)
\nEMEA Communications Department
\n+44 (0) 786 601 1272
\nEMEA-comms@eisai.net<\/p>\n

Biogen Inc.<\/span>
Natacha Gassenbach<\/span>
+ 1<\/span>–<\/span>857<\/span>–<\/span>777<\/span>–<\/span>6573<\/span>
public.affairs@biogen.com<\/span><\/p>\n

\n
<\/div>\n<\/div>\n
Investor Contacts:<\/span><\/strong>
Eisai Co., Ltd.<\/span>
Investor Relations<\/span> Department<\/span>
TEL: +81 (0) 3<\/span>–<\/span>3817<\/span>–<\/span>512<\/span>2<\/span><\/p>\n

Biogen Inc.<\/span>
Mike Hencke<\/span>
+ 1<\/span>–<\/span>781<\/span>–<\/span>464<\/span>–<\/span>2442<\/span>
IR@biogen.com<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"
Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with LEQEMBI\u2122
\nTreatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials<\/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-6386","post","type-post","status-publish","format-standard","hentry","category-news-en"],"_links":{"self":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/6386"}],"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=6386"}],"version-history":[{"count":6,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/6386\/revisions"}],"predecessor-version":[{"id":6393,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/6386\/revisions\/6393"}],"wp:attachment":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/media?parent=6386"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/categories?post=6386"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/tags?post=6386"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with LEQEMBI\u2122<\/h3>\n