Organon Expands Tofidence Label With FDA Approval for Additional Indications

MT Newswires Live06-10

Organon (OGN) said Wednesday that the US Food and Drug Administration has approved a supplemental Biologics License Application expanding the indications for Tofidence, a biosimilar to Actemra.

The expanded label covers treatment of cytokine release syndrome after CAR T-cell therapy and use in hospitalized COVID-19 patients aged 2 and older requiring oxygen support or ventilatory assistance, the company added.

Organon said the expanded approval helps improve access to high-cost biologic treatments, but also noted that the drug is associated with serious safety risks, including infections such as tuberculosis and potential liver injury.

Tofidence was first approved in 2024 and is already indicated for rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis, it added.

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/2642425542?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-06-10 20:03","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2642425542","market":"sg","top_or_hot":-1,"title":"Organon Expands Tofidence Label With FDA Approval for Additional Indications","media":"MT Newswires Live","content":"<html><body><p> Organon (OGN) said Wednesday that the US Food and Drug Administration has approved a supplemental Biologics License Application expanding the indications for Tofidence, a biosimilar to Actemra.</p><p>The expanded label covers treatment of cytokine release syndrome after CAR T-cell therapy and use in hospitalized COVID-19 patients aged 2 and older requiring oxygen support or ventilatory assistance, the company added.</p><p>Organon said the expanded approval helps improve access to high-cost biologic treatments, but also noted that the drug is associated with serious safety risks, including infections such as tuberculosis and potential liver injury.</p><p>Tofidence was first approved in 2024 and is already indicated for rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis, it added.</p></body></html>","source":"mtnewswires_news","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>Organon Expands Tofidence Label With FDA Approval for Additional Indications</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\">\nOrganon Expands Tofidence Label With FDA Approval for Additional Indications\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time\">2026-06-10 20:03</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> Organon (OGN) said Wednesday that the US Food and Drug Administration has approved a supplemental Biologics License Application expanding the indications for Tofidence, a biosimilar to Actemra.</p><p>The expanded label covers treatment of cytokine release syndrome after CAR T-cell therapy and use in hospitalized COVID-19 patients aged 2 and older requiring oxygen support or ventilatory assistance, the company added.</p><p>Organon said the expanded approval helps improve access to high-cost biologic treatments, but also noted that the drug is associated with serious safety risks, including infections such as tuberculosis and potential liver injury.</p><p>Tofidence was first approved in 2024 and is already indicated for rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis, it added.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU2065171402.SGD","symbol_name":"M&G (LUX) GLOBAL MAXIMA \"A\" (SGD) INC","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2642425542","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2642425542","pubTimestamp":1781093014,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"Organon  said Wednesday that the US Food and Drug Administration has approved a supplemental Biologics License Application expanding the indications for Tofidence, a biosimilar to Actemra.The expanded label covers treatment of cytokine release syndrome after CAR T-cell therapy and use in hospitalized COVID-19 patients aged 2 and older requiring oxygen support or ventilatory assistance, the company added.Organon said the expanded approval helps improve access to high-cost biologic treatments, but also noted that the drug is associated with serious safety risks, including infections such as tuberculosis and potential liver injury.Tofidence was first approved in 2024 and is already indicated for rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis, it added.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU2065171402.SGD":"M&G (LUX) GLOBAL MAXIMA \"A\" (SGD) INC","BK4007":"制药","LU2065169927.USD":"M&G (LUX) GLOBAL MAXIMA \"A\" (USD) ACC","LABU":"三倍做多标普生物-Direxion","BK4588":"碎股","OGN":"Organon & Co","LU2065171311.SGD":"M&G (LUX) GLOBAL MAXIMA \"A\" (SGD) ACC","BK4559":"巴菲特持仓","BK4585":"ETF&股票定投概念","LU2065170008.USD":"M&G (LUX) GLOBAL MAXIMA \"A\" (USD) INC"},"translate_title":"Organon扩大Tofidence标签并获得FDA批准用于其他适应症","themeId":"f6f7c9f6a0174df79daf9f1dfd21f836","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"OGN":1,"LABU":1.5},"content_text":"Organon (OGN) said Wednesday that the US Food and Drug Administration has approved a supplemental Biologics License Application expanding the indications for Tofidence, a biosimilar to Actemra.The expanded label covers treatment of cytokine release syndrome after CAR T-cell therapy and use in hospitalized COVID-19 patients aged 2 and older requiring oxygen support or ventilatory assistance, the company added.Organon said the expanded approval helps improve access to high-cost biologic treatments, but also noted that the drug is associated with serious safety risks, including infections such as tuberculosis and potential liver injury.Tofidence was first approved in 2024 and is already indicated for rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis, it added.","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":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"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,"isLaohu8Offline":false,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.44.0","shortVersion":"4.44.0","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/2642425542","isCrawlerRequest":true}