Lilly's Zepbound Receives FDA Approval for Sleep Apnea

Zacks12-23 21:16

Eli Lilly and Company LLY announced that the FDA has approved its popular obesity drug, Zepbound (tirzepatide) for treating moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. OSA...

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OSA...</p>\n\n<a href=\"https://finance.yahoo.com/news/lillys-zepbound-receives-fda-approval-131600465.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>Lilly's Zepbound Receives FDA Approval for Sleep Apnea</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\">\nLilly's Zepbound Receives FDA Approval for Sleep Apnea\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-12-23 21:16 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/lillys-zepbound-receives-fda-approval-131600465.html><strong>Zacks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Eli Lilly and Company LLY announced that the FDA has approved its popular obesity drug, Zepbound (tirzepatide) for treating moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. OSA...</p>\n\n<a href=\"https://finance.yahoo.com/news/lillys-zepbound-receives-fda-approval-131600465.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":"LU0354030511.USD","symbol_name":"ALLSPRING  U.S. LARGE CAP GROWTH \"I\" (USD) ACC","start_time":0,"source_url":"https://finance.yahoo.com/news/lillys-zepbound-receives-fda-approval-131600465.html","article_id":"2493769020","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/HNGK8KXbnuM7D3xIxBkleg--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/00ec4a55c0f0d99f7e816f5da7894e0c"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2493769020","pubTimestamp":1734959760,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Eli Lilly and Company LLY announced that the FDA has approved its popular obesity drug, Zepbound  for treatingmoderate-to-severe obstructive sleep apnea  in adults with obesity. OSA is a common sleep-related breathing disorder that causes repeated interruptions in breathing  or shallow breathing during sleep. OSA marks the second indication for Zepbound. The drug was approved to treat obesity or overweight issues in November 2023.With the approval, Zepbound becomes thefirst and only prescription drug approved for treating for adults with moderate-to-severe OSA and obesity.LLY’s stock was up 1.4% on Friday. It is also up in-premarket trading on Monday in response to the new approval. Also, rival Novo Nordisk NVO announced disappointing data from a late-stage study on its next-generation obesity drug, CagriSema, on Friday, which also pushed LLY’s stock up.However, quarter-over-quarter growth of Zepbound and Mounjaro in 2024 has been impacted by supply and channel dynamics. Mounjaro and Z","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0354030511.USD":"ALLSPRING  U.S. LARGE CAP GROWTH \"I\" (USD) ACC","BK4516":"特朗普概念","NVO":"诺和诺德","SG9999017495.SGD":"UGDP UNITED GLOBAL QUALITY GROWTH \"B\" (SGD) ACC","BK4532":"文艺复兴科技持仓","BK4599":"减肥药","LU1917777945.USD":"安联专题基金Cl AT Acc","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","LU1974910355.USD":"Allianz Thematica Cl AMg DIS USD","LU2089984988.USD":"MANULIFE GF HEALTHCARE \"AA\" (USD) ACC","SG9999018865.SGD":"United Global Quality Growth Fd Cl Dist SGD-H","BK4585":"ETF&股票定投概念","LU1267930730.SGD":"富兰克林美国机遇基金AS Acc SGD (CPF)","LU0238689110.USD":"贝莱德环球动力股票基金","LU0109391861.USD":"富兰克林美国机遇基金A Acc","LLY":"礼来","AMGN":"安进","LU2324357040.USD":"HSBC GIF GLOBAL EQUITY SUSTAINABLE HEALTHCARE \"AC\" (USD) ACC","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","BK4007":"制药","LU0256863902.USD":"ALLIANZ US EQUITY \"AT\" (USD) ACC","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","LU2461242641.AUD":"WELLINGTON US QUALITY GROWTH \"A\" (AUDHDG) ACC","GB00BDT5M118.USD":"天利环球扩展Alpha基金A Acc","LU0672654240.SGD":"FTIF - Franklin US Opportunities A Acc SGD-H1","LU1623119135.USD":"Natixis Mirova Global Sustainable Equity R-NPF/A USD","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","LU2211815571.USD":"ALLIANZ POSITIVE CHANGE \"AT\" (USD) ACC","LU0820561909.HKD":"ALLIANZ INCOME AND GROWTH \"AM\" (HKD) INC","BK4588":"碎股","LU1069344957.HKD":"AB SICAV I - AMERICAN GROWTH PORTFOLIO \"AD\" (HKD) INC","SG9999015945.SGD":"LionGlobal Disruptive Innovation Fund A SGD","LU2063271972.USD":"富兰克林创新领域基金","LU0058720904.USD":"联博国际健康护理基金A","LU2361044949.HKD":"WELLINGTON US QUALITY GROWTH \"A\" (HKD) ACC","IE00BK4W5L77.USD":"HSBC GLOBAL FUNDS ICAV US EQUITY INDEX \"HC\" (USD) ACC","LU1061106388.HKD":"BGF WORLD HEALTHSCIENCE \"A2\" (HKDHDG) ACC","LU2361044865.SGD":"WELLINGTON US QUALITY GROWTH \"A\" (SGDHDG) ACC","LU1868836757.USD":"CT (LUX) I AMERICAN FUND \"2\" (USD) ACC","VKTX":"Viking Therapeutics, Inc.","LU0203201768.USD":"AB SICAV I - ALL MARKET INCOME PORTFOLIO \"AX\" (USD) INC","BK4581":"高盛持仓","LU0320765059.SGD":"FTIF - Franklin US Opportunities A Acc SGD","LU0106261372.USD":"SCHRODER ISF US LARGE CAP \"A\" ACC","SG9999018857.SGD":"United Global Quality Growth Fd Cl Acc SGD-H","IE00B1BXHZ80.USD":"Legg Mason ClearBridge - US Appreciation A Acc USD","LU0122379950.USD":"贝莱德世界健康科学A2","LU0198837287.USD":"UBS (LUX) EQUITY SICAV - USA GROWTH \"P\" (USD) ACC","SG9999001440.SGD":"United Global Dividend Equity Fund A SGD Dist","LU0154236417.USD":"BGF US FLEXIBLE EQUITY \"A2\" ACC"},"translate_title":"礼来公司的Zepbound获得FDA批准用于睡眠呼吸暂停","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LLY":1,"AMGN":1,"VKTX":1,"NVO":0.9},"content_text":"Eli Lilly and Company LLY announced that the FDA has approved its popular obesity drug, Zepbound (tirzepatide) for treating moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. OSA is a common sleep-related breathing disorder that causes repeated interruptions in breathing (apnea) or shallow breathing (hypopnea) during sleep. OSA marks the second indication for Zepbound. The drug was approved to treat obesity or overweight issues in November 2023.\nWith the approval, Zepbound becomes the first and only prescription drug approved for treating for adults with moderate-to-severe OSA and obesity.\nLLY’s stock was up 1.4% on Friday. It is also up in-premarket trading on Monday in response to the new approval. Also, rival Novo Nordisk NVO announced disappointing data from a late-stage study on its next-generation obesity drug, CagriSema, on Friday, which also pushed LLY’s stock up.\nLilly’s stock has risen 31.7% so far this year compared with an increase of 1.4% for the industry.\nImage Source: Zacks Investment Research\nMore on the FDA Approval for LLY’s Zepbound for OSA\nZepbound’s approval for OSA was based on data from SURMOUNT-OSA phase III studies, which showed that patients not on positive airway pressure (PAP) therapy taking Zepbound experienced 25 fewer breathing disruptions per hour compared to five with placebo. In adults taking PAP therapy, Zepbound led to 29 fewer breathing disruptions per hour compared to six with placebo. In addition to improved OSA symptoms, in adults with PAP therapy, Zepbound also led to an average weight loss of 20%. The studies also showed that around 50% of the patients experienced such improvements with Zepbound that they no longer had symptoms associated with OSA after one year.\nLilly’s regulatory application seeking approval of Zepbound for OSA is also under review in the EU.\nNew Indications to Expand LLY’s Tirzepatide Label\nOther than Zepbound, Lilly markets tirzepatide as Mounjaro for type II diabetes. Mounjaro and Zepbound have seen great success generating huge revenues for Lilly.\nLilly has also filed regulatory applications in the United States and EU to seek approval for tirzepatide for heart failure with preserved ejection fraction (HFpEF). A phase III cardiovascular outcome study is also ongoing.A phase II study in metabolic dysfunction-associated steatohepatitis (MASH) met its primary endpoint in 2024. Approval for these expanded indications can further boost tirzepatide’s sales.\nDespite a short time on the market, Mounjaro and Zepbound have become key top-line drivers for Lilly in 2024, with demand rising rapidly.\nHowever, quarter-over-quarter growth of Zepbound and Mounjaro in 2024 has been impacted by supply and channel dynamics. Mounjaro and Zepbound’s sales were hurt due to inventory issues in the third quarter. Nonetheless, Lilly is expanding its manufacturing capacity for Mounjaro and Zepbound in order to balance demand and supply. Since 2020, Lilly has committed more than $23 billion for manufacturing capacity for Zepbound and Mounjaro in the United States and Europe. Last week, the FDA removed Mounjaro and Zepbound from its shortage list after determining that Lilly’s supply is currently meeting or exceeding demand. All these efforts are expected to improve the supply of Mounjaro and Zepbound in future quarters.\nCompetition Heating Up in the Obesity Market\nZepbound faces strong competition from Novo Nordisk’s obesity drug, Wegovy, which includes an ingredient called semaglutide. Semaglutide is also approved as Ozempic pre-filled pen and Rybelsus oral tablet for type II diabetes. Novo Nordisk also faces periodic supply constraints and drug shortages of its semaglutide products. Wegovy is already approved to reduce cardiovascular risks. Novo Nordisk is also looking to expand Wegovy’s indication to patients with heart failure with preserved ejection fraction and obesity.\nSeveral companies like Amgen AMGN and Viking Therapeutics VKTX are making rapid progress in the development of novel GLP-1-based candidates for obesity in their clinical pipeline.\nLast month, Amgen announced 52-week top-line data from a phase II study on MariTide, its GIPR/GLP-1 receptor for obesity for obesity. The data showed that MariTide led to approximately 20% average weight loss over 52 weeks without reaching a weight loss plateau. Amgen began a phase II study on candidate in type II diabetes in the third quarter.\nAmgen plans to conduct a broad phase III program on MariTide across obesity, obesity-related conditions and type-II diabetes.\nAMGN and VKTX’s products can pose strong competition to Mounjaro/Zepbound and Ozempic/Wegovy in the future.\nLilly has a Zacks Rank #3 (Hold) currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\n\nEli Lilly and Company Price and Consensus\n\nEli Lilly and Company price-consensus-chart | Eli Lilly and Company Quote\n\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\nNovo Nordisk A/S (NVO) : Free Stock Analysis Report\nEli Lilly and Company (LLY) : Free Stock Analysis Report\nAmgen Inc. (AMGN) : Free Stock Analysis Report\nViking Therapeutics, Inc. (VKTX) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","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":"4.29.3","shortVersion":"4.29.3","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/2493769020"}