CHMP Endorses AstraZeneca's Fasenra in Rare Autoimmune Disease

Zacks09-24

AstraZeneca AZN announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the regulatory filing seeking label expansion in the EU for its blockbuster asthma ...

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/2470541244?lang=en_US&edition=fundamental","thumbnail":"https://s.yimg.com/uu/api/res/1.2/6pmiwRZRhtc7hxDNA3zxVQ--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/ef77d5a5eb4e72e4dd31ccfaf4ca4ccd","is_english":true,"pubTime":"2024-09-24 23:46","share_image_url":"https://static.laohu8.com/5f26f4a48f9cb3e29be4d71d3ba8c038","id":"2470541244","market":"us","top_or_hot":-1,"title":"CHMP Endorses AstraZeneca's Fasenra in Rare Autoimmune Disease","media":"Zacks","content":"<div>\n<p>AstraZeneca AZN announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the regulatory filing seeking label expansion in the EU for its blockbuster asthma ...</p>\n\n<a href=\"https://finance.yahoo.com/news/chmp-endorses-astrazenecas-fasenra-rare-154600386.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>CHMP Endorses AstraZeneca's Fasenra in Rare Autoimmune 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\">\nCHMP Endorses AstraZeneca's Fasenra in Rare Autoimmune Disease\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-09-24 23:46 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/chmp-endorses-astrazenecas-fasenra-rare-154600386.html><strong>Zacks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>AstraZeneca AZN announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the regulatory filing seeking label expansion in the EU for its blockbuster asthma ...</p>\n\n<a href=\"https://finance.yahoo.com/news/chmp-endorses-astrazenecas-fasenra-rare-154600386.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":"BK4213","symbol_name":"石油与天然气的勘探与生产","start_time":0,"source_url":"https://finance.yahoo.com/news/chmp-endorses-astrazenecas-fasenra-rare-154600386.html","article_id":"2470541244","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/6pmiwRZRhtc7hxDNA3zxVQ--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/ef77d5a5eb4e72e4dd31ccfaf4ca4ccd"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2470541244","pubTimestamp":1727192760,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"AstraZeneca AZN announced that the EMA’s Committee for Medicinal Products for Human Use  recommended approving the regulatory filing seeking label expansion in the EU for its blockbuster asthma drug Fasenra  in eosinophilic granulomatosis with polyangiitis  indication.EGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues. The AZN filing seeks marketing authorization for Fasenra as an add-on treatment for adult patients with relapsing or refractory EGPA.This recommendation is based on data from the phase III MANDARAstudy, which compared a single monthly injection of Fasenra to three injections per month of GSK’s GSK blockbuster drug, Nucala . This is also the first approved targeted therapy for EGPA. Data from this study showed that nearly 60% of patients treated with Fasenra achieved remission, which was comparable to GSK’s Nucala-treated patients. Around 41% of patients treated with Fasenra entirely stopped taking oral corticosteroids compared to 26% i","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4213":"石油与天然气的勘探与生产","EPS":"WisdomTree U.S. LargeCap Fund","HES":"赫斯","LU0300736062.USD":"FRANKLIN NATURAL RESOURCES \"A\" (USD) ACC","LU0122376428.USD":"贝莱德世界能源基金A2","BK4532":"文艺复兴科技持仓","GSK.UK":"葛兰素史克","AZN":"阿斯利康","LU1829250122.USD":"高盛欧洲核心股票组合Acc","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU0456854461.SGD":"JPMorgan Funds - Global Natural Resources A (acc) SGD","GSK":"葛兰素史克","BK4585":"ETF&股票定投概念","SEA":"U.S. Global Sea to Sky Cargo ETF","IE00B7SZLL34.SGD":"Legg Mason ClearBridge - Value A Acc SGD-H","BK4139":"生物科技","BK4211":"区域性银行","BK4007":"制药","PFS":"Provident Financial Services Inc","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","CHMP":"冠军工业","BK4195":"互助储蓄与抵押信贷金融服务","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","BK4588":"碎股","BK4568":"美国抗疫概念","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","BK4198":"医疗保健用品","LU0788109394.HKD":"BGF WORLD ENERGY \"A2\" (HKDHGD) ACC","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","LU1169590202.USD":"ALLSPRING (LUX)  U.S. SELECT EQUITY \"I\" (USD) ACC","LU1169589451.USD":"ALLSPRING (LUX)  U.S. SELECT EQUITY \"A\" (USD) ACC","BVS":"Bioventus Inc.","BK4097":"系统软件","OS":"Onestream Inc","LU2236285917.USD":"ALLIANZ GLOBAL INCOME \"AMG\" (USD) INC","LU0368265418.SGD":"Blackrock World Energy Fund A2 SGD-H","KRYS":"Krystal Biotech Inc.","BK4087":"商业印刷","LU0266512127.USD":"摩根大通环球自然资源 A(acc)","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","LU0300736492.USD":"FRANKLIN NATURAL RESOURCES \"A\" (USD) INC"},"translate_title":"CHMP认可阿斯利康的Fasenra治疗罕见自身免疫性疾病","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SEA":1,"PFS":1,"OS":1,"AZN":1,"HES":1,"GSK":1,"EPS":1,"CHMP":1,"BVS":1,"KRYS":0.9,"GSK.UK":0.6},"content_text":"AstraZeneca AZN announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the regulatory filing seeking label expansion in the EU for its blockbuster asthma drug Fasenra (benralizumab) in eosinophilic granulomatosis with polyangiitis (EGPA) indication.\nEGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues. The AZN filing seeks marketing authorization for Fasenra as an add-on treatment for adult patients with relapsing or refractory EGPA.\nThis recommendation is based on data from the phase III MANDARA study, which compared a single monthly injection of Fasenra to three injections per month of GSK’s GSK blockbuster drug, Nucala (mepolizumab). This is also the first approved targeted therapy for EGPA. Data from this study showed that nearly 60% of patients treated with Fasenra achieved remission, which was comparable to GSK’s Nucala-treated patients. Around 41% of patients treated with Fasenra entirely stopped taking oral corticosteroids compared to 26% in the Nucala arm.\nLast week, the FDA approved Fasenra in EGPA indication, also supported by data from the MANDARA study. The drug is already approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in the United States and Europe.\nIf approved, Fasenra will be the second biologic approved in the European Union to treat EGPA. A potential approval for the drug is also likely to benefit EGPA patients since there are limited treatment options. Per management, nearly half of EGPA patients fail to reach remission with current treatments. The AZN drug offers a more convenient option to patients — Fasenra requires a single monthly subcutaneous injection compared with three injections per month in the case of GSK’s Nucala.\nAZN Stock Performance\nYear to date, AstraZeneca’s shares have moved up 14.5% compared with the industry’s 23.5% rise.\nImage Source: Zacks Investment Research\nFasenra – A Key Top-line Driver for AZN\nFasenra is currently approved in more than 80 countries across the world, including the United States, European Union and Japan for SEA. The drug added sales worth $781 million to AstraZeneca’s top line in the first half of 2024, up 6% year over year. Sales of the drug have been rising, driven by strong demand growth and market share.\nAstraZeneca is evaluating the drug in several label expansion studies for eosinophil-driven diseases, including chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP) and hypereosinophilic syndrome (HES). Continued label expansion for Fasenra into additional indications and patient populations should boost drug sales in the days ahead.\nAnother Clinical Setback for Daiichi-Partnered Drug This Month\nIn a separate press release, AstraZeneca reported results from the late-stage TROPION-Breast01 study, which evaluated its investigational antibody drug conjugate, datopotamab deruxtecan (Dato-DXd), in patients with a certain type of breast cancer. The drug is being developed in partnership with Japan-based Daiichi Sankyo.\nThe study did not achieve statistical significance in the final overall survival (OS) analysis, one of the dual primary endpoints of the study. The study had previously met the other dual primary endpoint of progression-free survival (PFS).\nManagement intends to share results from this study with regulatory authorities to determine its next steps for the clinical program evaluating Dato-DXd in breast cancer indication.\nThis is the second clinical setback for Dato-DXd this month. Earlier, AZN reported detailed results from the phase III TROPION-Lung01 study on the drug in certain patients with non-small cell lung cancer (NSCLC). Data from this study also showed that the treatment with the drug did not achieve statistical significance in OS, one of the study’s dual primary endpoints. This study had previously achieved the other primary endpoint of PFS.\nAZN’s Zacks Rank\nAstraZeneca currently carries a Zacks Rank #3 (Hold).\n\nAstraZeneca PLC Price\n\nAstraZeneca PLC price | AstraZeneca PLC Quote\n\n \nOur Key Picks Among Biotech Stocks\nSome better-ranked stocks include Bioventus BVS and Krystal Biotech KRYS, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn the past 60 days, estimates for Bioventus’ 2024 earnings per share (EPS) have risen from 27 cents to 40 cents. Estimates for 2025 have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 115.5%.\nBVS’ earnings beat estimates in three of the last four quarters and missed the mark on one occasion. Bioventus delivered a four-quarter average earnings surprise of 102.86%.\nIn the past 60 days, estimates for Krystal Biotech’s 2024 EPS have risen from $2.09 to $2.38. Estimates for 2025 have increased from $4.33 to $7.31 during the same period. Year to date, Krystal Biotech’s shares have surged 45.3%.\nEarnings of Krystal Biotech beat estimates in three of the last four quarters and missed the mark on one occasion. Krystal Biotech delivered a four-quarter average earnings surprise of 45.95%.\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\nAstraZeneca PLC (AZN) : Free Stock Analysis Report\nGSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report\nKrystal Biotech, Inc. (KRYS) : Free Stock Analysis Report\nBioventus Inc. (BVS) : 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":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"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/2470541244"}