Eli Lilly Secures Approval for Alzheimer's Drug Kisunla in Japan

Zacks09-25

Eli Lilly LLY announced that its Alzheimer's disease (AD) drug Kisunla (donanemab) has been approved for use in Japan. The drug will treat early symptomatic AD in adults with mild cognitive impairment...

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The drug will treat early symptomatic AD in adults with mild cognitive impairment...</p>\n\n<a href=\"https://finance.yahoo.com/news/eli-lilly-secures-approval-alzheimers-154500244.html\">Source Link</a>\n\n</div>\n","source":"yahoofinance","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Eli Lilly Secures Approval for Alzheimer's Drug Kisunla in Japan</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nEli Lilly Secures Approval for Alzheimer's Drug Kisunla in Japan\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-09-25 23:45 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/eli-lilly-secures-approval-alzheimers-154500244.html><strong>Zacks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Eli Lilly LLY announced that its Alzheimer's disease (AD) drug Kisunla (donanemab) has been approved for use in Japan. The drug will treat early symptomatic AD in adults with mild cognitive impairment...</p>\n\n<a href=\"https://finance.yahoo.com/news/eli-lilly-secures-approval-alzheimers-154500244.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0354030438.USD","symbol_name":"富国美国大盘成长基金Cl A Acc","start_time":0,"source_url":"https://finance.yahoo.com/news/eli-lilly-secures-approval-alzheimers-154500244.html","article_id":"2470296353","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/qi8AmKRuXk4zL7mGsiR5yg--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/60c096e1e24bb285c41a58d325d8d707"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2470296353","pubTimestamp":1727279100,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Eli Lilly LLY announced that its Alzheimer's disease  drug Kisunla  has been approved for use in Japan. The drug will treat early symptomatic AD in adults with mild cognitive impairment  and those with the mild dementia stage of AD, with confirmed amyloid pathology.Japan is the second major market in which Kisunla has been approved for use. LLY received its first approval for the drug in the United States this July.Both these approvals are based on data from the TRAILBLAZER-ALZ 2 phase III study, which showed that treatment with Kisunla slowed cognitive and functional decline by up to 35% in patients with less advanced disease compared to placebo at 18 months. It also showed that Kisunla reduced participants' risk of progressing to the next clinical stage of disease by up to 39%. A monthly intravenous infusion of Kisunla reduced amyloid plaques on average by 84% at 18 months compared with the start of the study in the overall population of participants.The AD target market is highly co","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0354030438.USD":"富国美国大盘成长基金Cl A Acc","LU0256863811.USD":"ALLIANZ US EQUITY \"A\" INC","BK4534":"瑞士信贷持仓","BK4585":"ETF&股票定投概念","BK4533":"AQR资本管理(全球第二大对冲基金)","LLY":"礼来","BIIB":"渤健公司","LU0234570918.USD":"高盛全球核心股票组合Acc Close","IE0004445239.USD":"JANUS HENDERSON US FORTY \"A2\" (USD) ACC","LU0109391861.USD":"富兰克林美国机遇基金A Acc","LU0238689110.USD":"贝莱德环球动力股票基金","IE00B894F039.SGD":"Legg Mason ClearBridge - US Aggressive Growth A Acc SGD-H","LU0417517546.SGD":"Allianz US Equity Cl AT Acc SGD","LU0708995401.HKD":"FRANKLIN U.S. OPPORTUNITIES \"A\" (HKD) ACC","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","LU1551013342.USD":"Allianz Income and Growth Cl AMg2 DIS USD","GB00BDT5M118.USD":"天利环球扩展Alpha基金A Acc","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","LU0256863902.USD":"ALLIANZ US EQUITY \"AT\" (USD) ACC","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","IE00BJT1NW94.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (SGDHDG) ACC","BK4532":"文艺复兴科技持仓","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","IE00BJLML261.HKD":"HSBC GLOBAL EQUITY INDEX \"HCH\" (HKD) ACC","LU1280957306.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQUITIES \"AUP\" (USD) INC","IE00B19Z9P08.USD":"LEGG MASON CLEARBRIDGE US AGGRESSIVE GROWTH \"A\" (USD) INC","LU0094547139.USD":"abrdn SICAV I - GLOBAL SUSTAINABLE EQUITY FUND \"A\" (USD) ACC","LU0079474960.USD":"联博美国增长基金A","LU0058720904.USD":"联博国际健康护理基金A","IE00B19Z9Z06.USD":"Legg Mason ClearBridge - US Aggressive Growth A Acc USD","LU1061106388.HKD":"BGF WORLD HEALTHSCIENCE \"A2\" (HKDHDG) ACC","IE00BK4W5L77.USD":"HSBC GLOBAL FUNDS ICAV US EQUITY INDEX \"HC\" (USD) ACC","LU0471298694.HKD":"BGF NUTRITION \"A2\" (HKD) ACC","LU0006306889.USD":"SCHRODER ISF US LARGE CAP \"A\" (USD) INC AV","IE00BK4W5M84.HKD":"HSBC GLOBAL FUNDS ICAV US EQUITY INDEX \"HC\" (HKD) ACC","LU1035775433.USD":"AB SICAV I - AMERICAN GROWTH PORTFOLIO \"AD\" (USD) INC","LU0882574055.USD":"富达全球健康医疗A ACC","LU0106261372.USD":"SCHRODER ISF US LARGE CAP \"A\" ACC","IE00B1BXHZ80.USD":"Legg Mason ClearBridge - US Appreciation A Acc USD","LU0672654240.SGD":"FTIF - Franklin US Opportunities A Acc SGD-H1","PRTA":"Prothena Corporation plc","SAVAW":"Cassava Sciences Warrants","LU0122379950.USD":"贝莱德世界健康科学A2","MCI":"Babson Capital Corporate Investors","LU0061475181.USD":"THREADNEEDLE (LUX) AMERICAN \"AU\" (USD) ACC","BK4007":"制药","SAVA":"Cassava Sciences Inc","BK4516":"特朗普概念","LU0354030511.USD":"ALLSPRING  U.S. LARGE CAP GROWTH \"I\" (USD) ACC","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC"},"translate_title":"礼来公司阿尔茨海默病药物Kisunla在日本获得批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SAVA":1,"PRTA":1,"MCI":1,"BIIB":1,"LLY":1,"SAVAW":0.9},"content_text":"Eli Lilly LLY announced that its Alzheimer's disease (AD) drug Kisunla (donanemab) has been approved for use in Japan. The drug will treat early symptomatic AD in adults with mild cognitive impairment (MCI) and those with the mild dementia stage of AD, with confirmed amyloid pathology.\nJapan is the second major market in which Kisunla has been approved for use. LLY received its first approval for the drug in the United States this July.\nBoth these approvals are based on data from the TRAILBLAZER-ALZ 2 phase III study, which showed that treatment with Kisunla slowed cognitive and functional decline by up to 35% in patients with less advanced disease compared to placebo at 18 months. It also showed that Kisunla reduced participants' risk of progressing to the next clinical stage of disease by up to 39%. A monthly intravenous infusion of Kisunla reduced amyloid plaques on average by 84% at 18 months compared with the start of the study in the overall population of participants.\nThis latest approval makes Lilly’s Kisunla the second drug to be approved in Japan that directly targets a specific cause of the disease — amyloid plaques. The first drug Leqembi, which is marketed by Biogen BIIB and Japan-partnered Eisai, was approved for use last year. The Biogen-Eisai drug was also approved for use by the FDA last year.\nLLY Stock Performance\nYear to date, Eli Lilly’s shares have surged 58.6% compared with the industry’s 22.4% rise.\nImage Source: Zacks Investment Research\nWhy the Japan Approval for LLY’s Kisunla Matters\nLilly considers Japan to be a major market for Kisunla. Management estimates that the number of dementia patients in Japan is expected to be more than five million by 2030. The most common form of dementia, AD, accounts for more than 67% of dementia cases in Japan. Lilly believes that this number is expected to rise significantly due to the country's rapidly aging population.\nDoes LLY’s Kisunla Have Any Competitive Advantage Over Leqembi?\nPer Lilly, Kisunla is the only amyloid-targeting therapy that can be discontinued when amyloid plaques clear up, as shown by a PET scan. This will lower treatment costs and burden for patients. In the TRAILBLAZER-ALZ 2 phase III study, around 47% of participants completed treatment at 12 months and 17% completed treatment at six months.\nTreatment with the Lilly drug requires the intravenous (IV) administration of a single dose once every four weeks compared with Biogen/Eisai’s Leqembi, which requires IV dosing once every two weeks.\nAD is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and amyloid beta (Aβ) plaques in the brain. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with this disease.\nOther Players in the AD Space\nThe AD target market is highly competitive as several other pharma companies like Cassava Sciences SAVA and Prothena PRTA are developing their antibody candidates targeting the AD indication.\nCassava Sciences is conducting a phase III program consisting of two global studies on its orally-administered drug simufilam in patients with mild-to-moderate AD dementia. While SAVA expects top-line data from the 52-week RETHINK-ALZ study before 2024-end, it expects to report data from the 76-week REFOCUS-ALZ study by mid-2025.\nProthena is evaluating multiple AD candidates in early-stage studies targeting AD indication. PRTA is evaluating AD drug PRX012, also an amyloid-targeting therapy, in an early-stage study. Prothena is also developing a dual Aβ-tau vaccine, PRX123, a potential prevention and treatment for AD.\n\nEli Lilly and Company Price\n\nEli Lilly and Company price | Eli Lilly and Company Quote\n\n \nLLY Zacks Rank\nEli Lilly currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nBiogen Inc. (BIIB) : Free Stock Analysis Report\nEli Lilly and Company (LLY) : Free Stock Analysis Report\nProthena Corporation plc (PRTA) : Free Stock Analysis Report\nCassava Sciences, Inc. (SAVA) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"Product Release,Policy And Regulatory","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.1","shortVersion":"4.29.1","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2470296353"}