EMA Panel Endorses Lilly's Omvoh for Expanded Use in Crohn's Disease

Zacks12-16

Eli Lilly LLY announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approving its IL-23p19 antibody Omvoh (mirikizumab) for expanded use in Crohn’s disease (CD)....

Source Link

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2491640694?lang=en_US&edition=fundamental","thumbnail":"https://s.yimg.com/uu/api/res/1.2/qi8AmKRuXk4zL7mGsiR5yg--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/60c096e1e24bb285c41a58d325d8d707","is_english":true,"pubTime":"2024-12-16 20:23","share_image_url":"https://static.laohu8.com/5f26f4a48f9cb3e29be4d71d3ba8c038","id":"2491640694","market":"us","top_or_hot":-1,"title":"EMA Panel Endorses Lilly's Omvoh for Expanded Use in Crohn's Disease","media":"Zacks","content":"<div>\n<p>Eli Lilly LLY announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approving its IL-23p19 antibody Omvoh (mirikizumab) for expanded use in Crohn’s disease (CD)....</p>\n\n<a href=\"https://finance.yahoo.com/news/ema-panel-endorses-lillys-omvoh-122300353.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>EMA Panel Endorses Lilly's Omvoh for Expanded Use in Crohn's Disease</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\">\nEMA Panel Endorses Lilly's Omvoh for Expanded Use in Crohn's Disease\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-12-16 20:23 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/ema-panel-endorses-lillys-omvoh-122300353.html><strong>Zacks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Eli Lilly LLY announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approving its IL-23p19 antibody Omvoh (mirikizumab) for expanded use in Crohn’s disease (CD)....</p>\n\n<a href=\"https://finance.yahoo.com/news/ema-panel-endorses-lillys-omvoh-122300353.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":"LU0058720904.USD","symbol_name":"联博国际健康护理基金A","start_time":0,"source_url":"https://finance.yahoo.com/news/ema-panel-endorses-lillys-omvoh-122300353.html","article_id":"2491640694","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=2491640694","pubTimestamp":1734351780,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Eli Lilly LLY announced that the EMA’s Committee for Medicinal Products for Human Use  recommended approving its IL-23p19 antibody Omvoh  for expanded use in Crohn’s disease .The CHMP has recommended Omvoh to treat adults with moderately to severely active CD, who have had an inadequate response with, lost response to, or are intolerant to conventional or biologic therapies. A final decision from the European Commission is now expected in the next one or two months.This positive recommendation is based on data from the phase III VIVID-1 study, which showed that treatment with Omvoh was effective in CD patients with or without prior biologic failure. Per Lilly, this is the first pivotal study to show benefit in hard-to-treat CD patients. A similar regulatory filing for the drug is also under review with the FDA with a final decision expected in first-half 2025, also supported by data from the VIVID-1 study.Omvoh is currently approved in more than 44 countries, including the United State","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0058720904.USD":"联博国际健康护理基金A","LU1267930813.SGD":"FRANKLIN TEMPLETON SHARIAH GLOBAL EQUITY \"AS\" (SGD) ACC","LU0661504455.SGD":"Blackrock Global Equity Income A5 SGD-H","SG9999015945.SGD":"LionGlobal Disruptive Innovation Fund A SGD","IE00BK4W5L77.USD":"HSBC GLOBAL FUNDS ICAV US EQUITY INDEX \"HC\" (USD) ACC","LU2361044949.HKD":"WELLINGTON US QUALITY GROWTH \"A\" (HKD) ACC","BK4588":"碎股","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","LU0106261372.USD":"SCHRODER ISF US LARGE CAP \"A\" ACC","LU0672654240.SGD":"FTIF - Franklin US Opportunities A Acc SGD-H1","LU2361045086.USD":"WELLINGTON US QUALITY GROWTH \"A\" (USD) ACC","LU0096364046.USD":"CT (LUX) I AMERICAN \"DU\" (USD) ACC","IE00BGHQF631.EUR":"GUINNESS GLOBAL EQUITY INCOME \"C\" (EUR) ACC","LU1291159041.SGD":"CPR Invest - Global Silver Age A2 Acc SGD-H","LU1244550221.USD":"FRANKLIN GLOBAL MULTI-ASSET  INCOME \"A\" (USDHEDGED) INC (M)","BK4504":"桥水持仓","LU0708995401.HKD":"FRANKLIN U.S. OPPORTUNITIES \"A\" (HKD) ACC","IE00B3PB1722.GBP":"GUINNESS GLOBAL EQUITY INCOME \"C\" (GBP) INC","LU2602419157.SGD":"HSBC ISLAMIC GLOBAL EQUITY INDEX \"AC\" (SGD) ACC","JNJ":"强生","SG9999001176.USD":"United Global Healthcare Acc USD","LU1496350171.SGD":"FRANKLIN DIVERSIFIED BALANCED \"A\" (SGDHDG) ACC","LU0256863811.USD":"ALLIANZ US EQUITY \"A\" INC","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","LU0211328371.USD":"TEMPLETON GLOBAL EQUITY INCOME \"A\" (MDIS) (USD)   INC","SG9999017495.SGD":"UGDP UNITED GLOBAL QUALITY GROWTH \"B\" (SGD) ACC","LU1035775433.USD":"AB SICAV I - AMERICAN GROWTH PORTFOLIO \"AD\" (USD) INC","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","BK4516":"特朗普概念","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H","LU0128525929.USD":"TEMPLETON GLOBAL \"A\" (USD) ACC","ABBV":"艾伯维公司","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","SG9999018865.SGD":"United Global Quality Growth Fd Cl Dist SGD-H","SG9999015952.SGD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (SGD) ACC","LU1988902786.USD":"FULLERTON LUX FUNDS GLOBAL ABSOLUTE ALPHA \"I\" (USD) ACC","LU2324357040.USD":"HSBC GIF GLOBAL EQUITY SUSTAINABLE HEALTHCARE \"AC\" (USD) ACC","CD":"秦淮数据","GB00BDT5M118.USD":"天利环球扩展Alpha基金A Acc","LU0098860793.USD":"FRANKLIN INCOME \"A\" INC","IBD":"Inspire Corporate Bond ETF","LLY":"礼来","BK4534":"瑞士信贷持仓","LU2237443622.USD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A Acc USD","LU2211815571.USD":"ALLIANZ POSITIVE CHANGE \"AT\" (USD) ACC","LU2089284900.SGD":"Allianz Global Sustainability Cl AM Dis H2-SGD","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","SG9999002232.USD":"Allianz Global High Payout USD","LU0234572021.USD":"高盛美国核心股票组合Acc","LU1934455194.USD":"AB SICAV I LOW VOLATILITY TOTAL RETURN EQUITY PORT \"A\" (USD) ACC"},"translate_title":"EMA小组批准礼来公司的Omvoh扩大用于克罗恩病","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ABBV":1,"CD":1,"IBD":1,"JNJ":1,"LLY":0.9},"content_text":"Eli Lilly LLY announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approving its IL-23p19 antibody Omvoh (mirikizumab) for expanded use in Crohn’s disease (CD).\nThe CHMP has recommended Omvoh to treat adults with moderately to severely active CD, who have had an inadequate response with, lost response to, or are intolerant to conventional or biologic therapies. A final decision from the European Commission is now expected in the next one or two months.\nThis positive recommendation is based on data from the phase III VIVID-1 study, which showed that treatment with Omvoh was effective in CD patients with or without prior biologic failure. Per Lilly, this is the first pivotal study to show benefit in hard-to-treat CD patients. A similar regulatory filing for the drug is also under review with the FDA with a final decision expected in first-half 2025, also supported by data from the VIVID-1 study.\nOmvoh is currently approved in more than 44 countries, including the United States and Europe, to treat adults with moderate-to-severely active ulcerative colitis (“UC”).\nLLY Stock’s Performance\nYear to date, Eli Lilly’s shares have risen 35.4% compared with the industry’s 6.3% growth.\nImage Source: Zacks Investment Research\nCompetition in the IBD Space\nBoth UC and CD indications are primary forms of inflammatory bowel disease (IBD), marked by chronic inflammation in the gastrointestinal tract. In recent years, there has been a surge in the prevalence of these disorders due to genetic factors, environmental factors and lifestyle changes. Immune system irregularities, higher diagnosis rates, increased focus on early diagnosis and favorable reimbursement policies in developed countries drive the demand for IBD treatments.\nThe targeted IBD market is highly competitive. Some key players in this space are AbbVie ABBV and Johnson & Johnson JNJ, which have the strongest portfolios of immunology drugs and pipeline candidates.\nABBV’s key immunology products, Skyrizi and Rinvoq, are performing extremely well, bolstered by approval across multiple IBD indications, which should support top-line growth in the next few years. AbbVie has already raked in nearly $10 billion from the combined product sales of both these drugs in the first nine months of 2024.\nABBV has also been engaged in an acquisition spree since the onset of this year to further strengthen its leadership in the immunology space. In 2024, it acquired smaller biotechs, Landos Biopharma and Celsius Therapeutics, which are making novel drugs for treating IBD. Last week, ABBV announced its intent to acquire privately-held Nimble Therapeutics for $200 million in cash to explore the potential of novel oral therapies in the immunology space.\nJ&J also boasts a strong immunology portfolio with blockbusters like Stelara and Tremfya. A much older drug, Stelara is already approved to treat several IBD indications, including CD and UC, across the United States and the European Union. J&J added more than $8 billion from Stelara sales in the first nine months of 2024.\nAnother successful drug in J&J’s portfolio is its newer immunology drug, Tremfya, which recorded sales of $2.7 billion in the first nine months of 2024. Tremfya was approved by the FDA for UC indication in September, with a similar regulatory filing under review in the European Union. It is also under review in both the United States and the European Union for CD indication. J&J expects Tremfya to be a $5 billion product with potential approvals in both CD and UC indications.\nSeveral other big drugmakers are developing new medicines with novel mechanisms of action to help patients with UC and CV achieve long-term clinical remission. These include Merck, Pfizer, Novartis, Sanofi, Gilead and Amgen. Some of these companies have also in-licensed rights to IBD candidates with improved clinical profiles from smaller drugmakers in the past two to three years.\n\nEli Lilly and Company Price\n\nEli Lilly and Company price | Eli Lilly and Company Quote\n\nLLY’s Zacks Rank\nEli Lilly currently carries a Zacks Rank #3 (Hold). 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\nJohnson & Johnson (JNJ) : Free Stock Analysis Report\nEli Lilly and Company (LLY) : Free Stock Analysis Report\nAbbVie Inc. (ABBV) : 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/2491640694"}