AZN Gets FDA Nod for Fasenra Label Expansion in Rare Disease

Zacks09-18

AstraZeneca AZN announced that the FDA has approved its marketed asthma drug, Fasenra (benralizumab) for a new indication. The regulatory body has now approved Fasenra for treating adult patients with...

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The regulatory body has now approved Fasenra for treating adult patients with...</p>\n\n<a href=\"https://finance.yahoo.com/news/azn-gets-fda-nod-fasenra-151200524.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>AZN Gets FDA Nod for Fasenra Label Expansion in Rare 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\">\nAZN Gets FDA Nod for Fasenra Label Expansion in Rare Disease\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-09-18 23:12 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/azn-gets-fda-nod-fasenra-151200524.html><strong>Zacks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>AstraZeneca AZN announced that the FDA has approved its marketed asthma drug, Fasenra (benralizumab) for a new indication. The regulatory body has now approved Fasenra for treating adult patients with...</p>\n\n<a href=\"https://finance.yahoo.com/news/azn-gets-fda-nod-fasenra-151200524.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":"BK4532","symbol_name":"文艺复兴科技持仓","start_time":0,"source_url":"https://finance.yahoo.com/news/azn-gets-fda-nod-fasenra-151200524.html","article_id":"2468531861","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=2468531861","pubTimestamp":1726672320,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"AstraZeneca AZN announced that the FDA has approved its marketed asthma drug, Fasenra  for a new indication. The regulatory body has now approved Fasenra for treating adult patients with eosinophilic granulomatosis with polyangiitis .EGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues and is the second approved indication for Fasenra.Fasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma .Shares of AstraZeneca have increased 16.6% so far this year compared with the industry’s rise of 25.9%.The FDA nod for Fasenra in EGPA was based on data from the phase III MANDARA study.The MANDARA head-to-head study compared a single monthly injection of Fasenra to three injections per month of GSK’s GSK blockbuster drug, Nucala , which until now was the only approved drug for EGPA.","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4532":"文艺复兴科技持仓","LU2468319806.SGD":"MANULIFE GF HEALTHCARE \"AA\" (SGDHDG) ACC","LU2362541273.HKD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (HKD) ACC","LU1829250122.USD":"高盛欧洲核心股票组合Acc","LU2362541513.USD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (USD) ACC","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","BK4585":"ETF&股票定投概念","SNY":"赛诺菲安万特","BK4139":"生物科技","LU0114720955.EUR":"SUSTAINABLE GLOBAL HEALTH CARE \"A\" INC","BK4007":"制药","LU2089984988.USD":"MANULIFE GF HEALTHCARE \"AA\" (USD) ACC","LU0823416689.USD":"BNP PARIBAS HEALTH CARE INNOVATORS \"C\" (USD) ACC","LU1974910355.USD":"Allianz Thematica Cl AMg DIS USD","LU1917777945.USD":"安联专题基金Cl AT Acc","LU0053666078.USD":"摩根大通基金-美国股票A（离岸）美元","LU2106854487.HKD":"ALLIANZ THEMATICA \"AMG\" (HKD) INC","BK4568":"美国抗疫概念","BK4588":"碎股","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","LU2023250504.SGD":"Allianz Thematica Cl AMg DIS H2-SGD","GSK.UK":"葛兰素史克","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","IE00BFXG1179.USD":"BNY MELLON U.S. EQUITY INCOME \"B\" (USD) INC","LU2362540622.SGD":"WELLINGTON NEXT GENERATION GLOBAL EQUITY \"A\" (SGDHDG) ACC","AZN":"阿斯利康","SEA":"U.S. Global Sea to Sky Cargo ETF","GSK":"葛兰素史克","LU0058720904.USD":"联博国际健康护理基金A","REGN":"再生元制药公司","LU2236285917.USD":"ALLIANZ GLOBAL INCOME \"AMG\" (USD) INC","LU0882574055.USD":"富达全球健康医疗A ACC"},"translate_title":"AZN获得FDA批准扩大罕见疾病Fasenra标签","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SNY":1,"SEA":1,"REGN":1,"AZN":1,"GSK":1,"GSK.UK":0.6},"content_text":"AstraZeneca AZN announced that the FDA has approved its marketed asthma drug, Fasenra (benralizumab) for a new indication. The regulatory body has now approved Fasenra for treating adult patients with eosinophilic granulomatosis with polyangiitis (“EGPA”).\nEGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues and is the second approved indication for Fasenra.\nFasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA).\nShares of AstraZeneca have increased 16.6% so far this year compared with the industry’s rise of 25.9%.\nImage Source: Zacks Investment Research\nLatest Approval for AZN’s Fasenra Based on MANDARA Study\nThe FDA nod for Fasenra in EGPA was based on data from the phase III MANDARA study.\nThe MANDARA head-to-head study compared a single monthly injection of Fasenra to three injections per month of GSK’s GSK blockbuster drug, Nucala (mepolizumab), which until now was the only approved drug for EGPA.\nData from the study showed that nearly 60% of patients who were treated with Fasenra achieved remission, which was comparable to GSK’s Nucala-treated patients.\nAlso, 41% of patients who were treated with Fasenra fully stopped taking oral corticosteroids compared to 26% of patients in the Nucala arm.\nThe latest approval of Fasenra is likely to offer a convenient single monthly subcutaneous injection to patients living with EGPA.\nAZN’s Fasenra a Key Revenue Driver\nFasenra is currently approved in more than 80 countries across the world, including the United States, European Union and Japan for SEA. Several label expansion studies are going on for Fasenra for eosinophil-driven diseases beyond severe asthma, like chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.\nFasenra generated sales worth $781 million in the first half of 2024, reflecting an increase of 6% year over year at a constant exchange rate. Sales of the drug have been rising, driven by strong demand growth and market share.\nContinued label expansion for Fasenra into additional indications and patient populations should boost drug sales in the days ahead.\nOther Players in the Respiratory Diseases Market\nApart from GSK’s Nucala, Sanofi SNY and Regeneron’s REGN Dupixent (dupilumab), an IL-4 and IL-13 inhibitor, is also approved in several countries, including the United States and EU, for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.\nREGN and SNY are jointly marketing Dupixent under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the drug’s global sales. The companies are also studying the drug in late-stage studies in a broad range of diseases driven by type II inflammation, like bullous pemphigoid and chronic pruritus of unknown origin.\nZacks Rank\nAstraZeneca 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\nRegeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report\nSanofi (SNY) : Free Stock Analysis Report\nAstraZeneca PLC (AZN) : Free Stock Analysis Report\nGSK PLC Sponsored ADR (GSK) : 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/2468531861"}