重庆小市民
2024-06-18
这篇文章不错，转发给大家看看
Alzheimer's in Focus as FDA Panel Endorses Lilly's Donanemab
免责声明：上述内容仅代表发帖人个人观点，不构成本平台的任何投资建议。
分享至
微信
复制链接
精彩评论
我们需要你的真知灼见来填补这片空白
打开APP，发表看法
APP内打开
发表看法
{"i18n":{"language":"zh_CN"},"detailType":1,"isChannel":false,"data":{"magic":2,"id":317984928710936,"tweetId":"317984928710936","gmtCreate":1718671643822,"gmtModify":1718671645257,"author":{"id":3548982422913331,"idStr":"3548982422913331","authorId":3548982422913331,"authorIdStr":"3548982422913331","name":"重庆小市民","avatar":"https://static.tigerbbs.com/03029d12634d7b5aee00d9418efd3207","vip":1,"userType":1,"introduction":"","boolIsFan":false,"boolIsHead":false,"crmLevel":5,"crmLevelSwitch":0,"individualDisplayBadges":[],"fanSize":0,"starInvestorFlag":false},"themes":[],"images":[],"coverImages":[],"html":"<html><head></head><body>这篇文章不错，转发给大家看看</body></html>","htmlText":"<html><head></head><body>这篇文章不错，转发给大家看看</body></html>","text":"这篇文章不错，转发给大家看看","highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/317984928710936","repostId":2442156671,"repostType":2,"repost":{"id":"2442156671","kind":"highlight","pubTimestamp":1718202120,"share":"https://ttm.financial/m/news/2442156671?lang=&edition=full","pubTime":"2024-06-12 22:22","market":"us","language":"en","title":"Alzheimer's in Focus as FDA Panel Endorses Lilly's Donanemab","url":"https://stock-news.laohu8.com/highlight/detail?id=2442156671","media":"Zacks","summary":"The lucrative Alzheimer’s disease market could have a second player soon, posing strong competition to Biogen BIIB and its Japan-based partner Eisai’s Leqembi, approved last year in the United States to reduce the cognitive decline associated with early Alzheimer’s disease.On Jun 10, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 11-0, unanimously recommending the approval of Eli Lilly’s LLY Alzheimer's disease drug, donanemab.However, with donanemab just one step away from approval, the Alzheimer’s market could soon get two drugs. Two products on the market should accelerate uptake as Eisai, Lilly and Biogen will invest in educating patients and physicians and building the necessary infrastructure to boost sales. The FDA committee’s endorsement of donanemab, in a way, reflects FDA’s optimistic approach for Aβ targeting Alzheimer’s treatments which have an acceptable benefit-risk profile.","content":"<html><body><p>The lucrative Alzheimer’s disease market could have a second player soon, posing strong competition to <strong>Biogen</strong> BIIB and its Japan-based partner Eisai’s Leqembi, approved last year in the United States to reduce the cognitive decline associated with early Alzheimer’s disease.</p>\n<p>On Jun 10, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted 11-0, unanimously recommending the approval of <strong>Eli Lilly</strong>’s LLY Alzheimer's disease drug, donanemab.</p>\n<p>The committee said that data from clinical studies on donanemab demonstrated substantial evidence of efficacy and a clinically meaningful slowdown in disease progression for early symptomatic Alzheimer’s patients. Overall, the committee voted that the benefits of donanemab outweighed the risks despite some safety concerns. Lilly is seeking approval for donanemab for the treatment of patients with mild Alzheimer’s disease.</p>\n<p>Alzheimer's disease is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and amyloid beta (Aβ) plaques in the brain. Both Leqembi and donanemab are Aβ targeting therapies. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with Alzheimer’s disease. However, anti-amyloid antibodies can cause a brain swelling side effect called amyloid-related imaging abnormalities (ARIA). In clinical studies, ARIA-E (ARIA - edema/effusions) was observed in 24% and ARIA-H (ARIA-hemorrhage/hemosiderin deposition) in 31% of donanemab-treated patients. However, to Lilly’s advantage, the panel said such risks could be addressed by “appropriate labeling and management.”</p>\n<p>Most analysts are now expecting donanemab to gain FDA approval with a broad label and a warning for ARIA. Leqembi’s label also has a similar warning for ARIA. A PDUFA date, however, has not been scheduled by the FDA for a decision on donanemab after the original decision was delayed for the need of the advisory meeting.</p>\n<p>Until Leqembi was approved, the drugs available in the market just treated the symptoms of the disease. Several companies have failed to develop safe and effective treatment options to treat this deadly brain disease despite making significant investments. Biogen/Eisai’s controversial medicine, Aduhelm, was approved by the FDA in 2021. However, in January 2024, Biogen discontinued the development and commercialization of Aduhelm as the drug failed to generate any significant sales due to a lack of access to Medicare beneficiaries.</p>\n<p>However, with donanemab just one step away from approval, the Alzheimer’s market could soon get two drugs. Two products on the market should accelerate uptake as Eisai, Lilly and Biogen will invest in educating patients and physicians and building the necessary infrastructure to boost sales. The FDA committee’s endorsement of donanemab, in a way, reflects FDA’s optimistic approach for Aβ targeting Alzheimer’s treatments which have an acceptable benefit-risk profile.</p>\n<p>Biogen/Eisai are also quite bullish on Leqembi’s progress. Though Leqembi has had a lackluster launch, Biogen and Eisai expect the sales of Leqembi to grow in 2024, with signs of acceleration seen in the first quarter. Biogen and Eisai believe it has the potential to generate blockbuster sales as there remains a massive unmet need for Alzheimer's disease.</p>\n<p>The Centers for Medicare & Medicaid Services has also granted broad reimbursement to Leqembi under Medicare plans. Leqembi is also approved in China and Japan, which could bring in additional sales going forward. Regulatory applications seeking the approval of Leqembi are under review in Europe.</p>\n<p><strong>Prothena Corporation</strong> PRTA, <strong>AC Immune</strong> ACIU and Cassava Sciences are also developing therapies for Alzheimer's disease. Prothena’s Alzheimer’s candidate is PRX012, a next-generation subcutaneous antibody targeting a key epitope at the N-terminus of Aβ. PRX012 is in early-stage development. The FDA has granted Fast Track Designation to PRX012 for the treatment of Alzheimer's disease. Prothena is also developing a dual Aβ-tau vaccine, PRX123, a potential prevention and treatment for Alzheimer's disease.</p>\n<p>AC Immune is conducting a phase III program consisting of two global studies of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. Top-line data from the 52-week RETHINK-ALZ study is expected by the end of 2024, while that from the second study, the 76-week REFOCUS-ALZ study, is expected by mid-year 2025.</p>\n<p>Though there are some challenges and administrative hurdles associated with the marketing of Alzheimer’s drugs, the entry of additional players should further raise disease awareness and benefit the Alzheimer’s market as a whole.</p>\n<p>Lilly and Biogen carry a Zacks Rank #3 (Hold) each. You can see <strong>the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here</strong></p>\n<p>Want 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</p>\n<p>Biogen Inc. (BIIB) : Free Stock Analysis Report</p>\n<p>Eli Lilly and Company (LLY) : Free Stock Analysis Report</p>\n<p><a href=\"https://laohu8.com/S/PRTA\">Prothena Corporation plc</a> (PRTA) : Free Stock Analysis Report</p>\n<p>AC Immune (ACIU) : Free Stock Analysis Report</p>\n<p>To read this article on Zacks.com click here.</p>\n<p>Zacks Investment Research</p></body></html>","source":"yahoofinance","collect":0,"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>Alzheimer's in Focus as FDA Panel Endorses Lilly's Donanemab</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\">\nAlzheimer's in Focus as FDA Panel Endorses Lilly's Donanemab\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-06-12 22:22 GMT+8 <a href=https://finance.yahoo.com/news/alzheimers-focus-fda-panel-endorses-142200727.html><strong>Zacks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>The lucrative Alzheimer’s disease market could have a second player soon, posing strong competition to Biogen BIIB and its Japan-based partner Eisai’s Leqembi, approved last year in the United States ...</p>\n\n<a href=\"https://finance.yahoo.com/news/alzheimers-focus-fda-panel-endorses-142200727.html\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"https://s.yimg.com/uu/api/res/1.2/HNGK8KXbnuM7D3xIxBkleg--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/00ec4a55c0f0d99f7e816f5da7894e0c","relate_stocks":{"LU2237443382.USD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A MIncA USD","BK4533":"AQR资本管理(全球第二大对冲基金)","LU2602419157.SGD":"HSBC ISLAMIC GLOBAL EQUITY INDEX \"AC\" (SGD) ACC","LU1551013425.SGD":"Allianz Income and Growth Cl AMg2 DIS H2-SGD","LU2237443549.SGD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A MIncA SGD-H","LU1551013342.USD":"Allianz Income and Growth Cl AMg2 DIS USD","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU2237443622.USD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A Acc USD","LU0114720955.EUR":"SUSTAINABLE GLOBAL HEALTH CARE \"A\" INC","PRTA":"Prothena Corporation plc","ACIU":"AC Immune SA","LLY":"礼来","LU2491049909.HKD":"WELLINGTON SUSTAINABLE OUTCOMES \"A\" (HKD) ACC","LU2237443978.SGD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A Acc SGD-H","LU0198837287.USD":"UBS (LUX) EQUITY SICAV - USA GROWTH \"P\" (USD) ACC","LU0820561909.HKD":"ALLIANZ INCOME AND GROWTH \"AM\" (HKD) INC","BK4585":"ETF&股票定投概念","ARIA":"阿里阿德","LU1804176565.USD":"EASTSPRING INV GLOBAL GROWTH EQUITY \"A\" (USD) ACC","LU2491050071.SGD":"WELLINGTON SUSTAINABLE OUTCOMES \"A\" (SGDHDG) ACC","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","LU0820561818.USD":"安联收益及增长平衡基金Cl AM DIS","LU2491050154.USD":"WELLINGTON SUSTAINABLE OUTCOMES \"A\" (USD) ACC","LU0058720904.USD":"联博国际健康护理基金A","LU2264538146.SGD":"Fullerton Lux Funds - Global Absolute Alpha A Acc SGD","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","LU0079474960.USD":"联博美国增长基金A","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","LU0882574139.USD":"富达环球消费行业基金A ACC","GB00BDT5M118.USD":"天利环球扩展Alpha基金A Acc","BK4007":"制药","LU1623119135.USD":"Natixis Mirova Global Sustainable Equity R-NPF/A USD","LU0256863811.USD":"ALLIANZ US EQUITY \"A\" INC","LU0466842654.USD":"HSBC ISLAMIC GLOBAL EQUITY INDEX \"A\" (USD) ACC","LU0097036916.USD":"贝莱德美国增长A2 USD","BIIB":"渤健公司","LU0640476718.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQ \"AU\" (USD) ACC","LU0882574055.USD":"富达全球健康医疗A ACC","LU0689472784.USD":"安联收益及增长基金Cl AM AT Acc","LU1712237335.SGD":"Natixis Mirova Global Sustainable Equity H-R-NPF/A SGD","LU2265009873.SGD":"Eastspring Investments - Global Growth Equity AS SGD-H","LU1280957306.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQUITIES \"AUP\" (USD) INC","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","LU0122379950.USD":"贝莱德世界健康科学A2","IE00B19Z9P08.USD":"LEGG MASON CLEARBRIDGE US AGGRESSIVE GROWTH \"A\" (USD) INC","LU1064131342.USD":"Fullerton Lux Funds - Global Absolute Alpha A Acc USD","IE0004445239.USD":"JANUS HENDERSON US FORTY \"A2\" (USD) ACC","BK4534":"瑞士信贷持仓"},"source_url":"https://finance.yahoo.com/news/alzheimers-focus-fda-panel-endorses-142200727.html","is_english":true,"share_image_url":"https://static.laohu8.com/5f26f4a48f9cb3e29be4d71d3ba8c038","article_id":"2442156671","content_text":"The lucrative Alzheimer’s disease market could have a second player soon, posing strong competition to Biogen BIIB and its Japan-based partner Eisai’s Leqembi, approved last year in the United States to reduce the cognitive decline associated with early Alzheimer’s disease.\nOn Jun 10, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted 11-0, unanimously recommending the approval of Eli Lilly’s LLY Alzheimer's disease drug, donanemab.\nThe committee said that data from clinical studies on donanemab demonstrated substantial evidence of efficacy and a clinically meaningful slowdown in disease progression for early symptomatic Alzheimer’s patients. Overall, the committee voted that the benefits of donanemab outweighed the risks despite some safety concerns. Lilly is seeking approval for donanemab for the treatment of patients with mild Alzheimer’s disease.\nAlzheimer's disease is a devastating neurodegenerative disorder characterized by the accumulation of tau tangles and amyloid beta (Aβ) plaques in the brain. Both Leqembi and donanemab are Aβ targeting therapies. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with Alzheimer’s disease. However, anti-amyloid antibodies can cause a brain swelling side effect called amyloid-related imaging abnormalities (ARIA). In clinical studies, ARIA-E (ARIA - edema/effusions) was observed in 24% and ARIA-H (ARIA-hemorrhage/hemosiderin deposition) in 31% of donanemab-treated patients. However, to Lilly’s advantage, the panel said such risks could be addressed by “appropriate labeling and management.”\nMost analysts are now expecting donanemab to gain FDA approval with a broad label and a warning for ARIA. Leqembi’s label also has a similar warning for ARIA. A PDUFA date, however, has not been scheduled by the FDA for a decision on donanemab after the original decision was delayed for the need of the advisory meeting.\nUntil Leqembi was approved, the drugs available in the market just treated the symptoms of the disease. Several companies have failed to develop safe and effective treatment options to treat this deadly brain disease despite making significant investments. Biogen/Eisai’s controversial medicine, Aduhelm, was approved by the FDA in 2021. However, in January 2024, Biogen discontinued the development and commercialization of Aduhelm as the drug failed to generate any significant sales due to a lack of access to Medicare beneficiaries.\nHowever, with donanemab just one step away from approval, the Alzheimer’s market could soon get two drugs. Two products on the market should accelerate uptake as Eisai, Lilly and Biogen will invest in educating patients and physicians and building the necessary infrastructure to boost sales. The FDA committee’s endorsement of donanemab, in a way, reflects FDA’s optimistic approach for Aβ targeting Alzheimer’s treatments which have an acceptable benefit-risk profile.\nBiogen/Eisai are also quite bullish on Leqembi’s progress. Though Leqembi has had a lackluster launch, Biogen and Eisai expect the sales of Leqembi to grow in 2024, with signs of acceleration seen in the first quarter. Biogen and Eisai believe it has the potential to generate blockbuster sales as there remains a massive unmet need for Alzheimer's disease.\nThe Centers for Medicare & Medicaid Services has also granted broad reimbursement to Leqembi under Medicare plans. Leqembi is also approved in China and Japan, which could bring in additional sales going forward. Regulatory applications seeking the approval of Leqembi are under review in Europe.\nProthena Corporation PRTA, AC Immune ACIU and Cassava Sciences are also developing therapies for Alzheimer's disease. Prothena’s Alzheimer’s candidate is PRX012, a next-generation subcutaneous antibody targeting a key epitope at the N-terminus of Aβ. PRX012 is in early-stage development. The FDA has granted Fast Track Designation to PRX012 for the treatment of Alzheimer's disease. Prothena is also developing a dual Aβ-tau vaccine, PRX123, a potential prevention and treatment for Alzheimer's disease.\nAC Immune is conducting a phase III program consisting of two global studies of simufilam in patients with mild-to-moderate Alzheimer’s disease dementia. Top-line data from the 52-week RETHINK-ALZ study is expected by the end of 2024, while that from the second study, the 76-week REFOCUS-ALZ study, is expected by mid-year 2025.\nThough there are some challenges and administrative hurdles associated with the marketing of Alzheimer’s drugs, the entry of additional players should further raise disease awareness and benefit the Alzheimer’s market as a whole.\nLilly and Biogen carry a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) 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\nAC Immune (ACIU) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","news_type":1,"symbols_score_info":{"ACIU":1,"ARIA":1,"BIIB":0.9,"LLY":1,"PRTA":1}},"isVote":1,"tweetType":1,"viewCount":1300,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":27,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/317984928710936"}
精彩评论