Roche Holding Ltd (RHHBY.US) Receives Approval for Ocrelizumab to Treat Lupus Nephritis

Stock News10-20

On October 20, Roche Holding Ltd (RHHBY.US) announced that ocrelizumab (marketed as Gazyva/Gazyvaro) has received FDA approval for a new indication to treat adult patients with active lupus nephritis (LN) who are receiving standard therapy. After an initial treatment consisting of four doses in the first year, the dosing frequency can be modified to twice a year. This drug is the first CD20-targeted therapy approved by the FDA for the treatment of lupus nephritis. The FDA's decision was primarily based on positive results from the Phase II NOBILITY study and the Phase III REGISTRY study. The REGISTRY study demonstrated that 46.4% of patients treated with ocrelizumab in combination with standard therapy (mycophenolate mofetil and corticosteroids) achieved complete renal response (CRR) at week 76, compared to 33.1% in the standard therapy group (adjusted difference of 13.4%, 95% CI: 2.0%-24.8%; P=0.0232). Additionally, the ocrelizumab group showed clinically meaningful improvements in complement levels, as well as reductions in anti-dsDNA antibodies, disease activity, and inflammation markers.

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/1191944764?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-10-20 21:10","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"1191944764","market":"other","top_or_hot":-1,"title":"Roche Holding Ltd (RHHBY.US) Receives Approval for Ocrelizumab to Treat Lupus Nephritis","media":"Stock News","content":"<p>On October 20, Roche Holding Ltd (RHHBY.US) announced that ocrelizumab (marketed as Gazyva/Gazyvaro) has received FDA approval for a new indication to treat adult patients with active lupus nephritis (LN) who are receiving standard therapy. After an initial treatment consisting of four doses in the first year, the dosing frequency can be modified to twice a year. This drug is the first CD20-targeted therapy approved by the FDA for the treatment of lupus nephritis. The FDA's decision was primarily based on positive results from the Phase II NOBILITY study and the Phase III REGISTRY study. The REGISTRY study demonstrated that 46.4% of patients treated with ocrelizumab in combination with standard therapy (mycophenolate mofetil and corticosteroids) achieved complete renal response (CRR) at week 76, compared to 33.1% in the standard therapy group (adjusted difference of 13.4%, 95% CI: 2.0%-24.8%; P=0.0232). Additionally, the ocrelizumab group showed clinically meaningful improvements in complement levels, as well as reductions in anti-dsDNA antibodies, disease activity, and inflammation markers.</p>","source":null,"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>Roche Holding Ltd (RHHBY.US) Receives Approval for Ocrelizumab to Treat Lupus Nephritis</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\">\nRoche Holding Ltd (RHHBY.US) Receives Approval for Ocrelizumab to Treat Lupus Nephritis\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1036600163\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/b3bf6d02ad1a6e9e7377eebbb162346a);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Stock News </p>\n<p class=\"h-time\">2025-10-20 21:10</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>On October 20, Roche Holding Ltd (RHHBY.US) announced that ocrelizumab (marketed as Gazyva/Gazyvaro) has received FDA approval for a new indication to treat adult patients with active lupus nephritis (LN) who are receiving standard therapy. After an initial treatment consisting of four doses in the first year, the dosing frequency can be modified to twice a year. This drug is the first CD20-targeted therapy approved by the FDA for the treatment of lupus nephritis. The FDA's decision was primarily based on positive results from the Phase II NOBILITY study and the Phase III REGISTRY study. The REGISTRY study demonstrated that 46.4% of patients treated with ocrelizumab in combination with standard therapy (mycophenolate mofetil and corticosteroids) achieved complete renal response (CRR) at week 76, compared to 33.1% in the standard therapy group (adjusted difference of 13.4%, 95% CI: 2.0%-24.8%; P=0.0232). Additionally, the ocrelizumab group showed clinically meaningful improvements in complement levels, as well as reductions in anti-dsDNA antibodies, disease activity, and inflammation markers.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4007","symbol_name":"制药","start_time":0,"source_url":"","article_id":"1191944764","we_media_id":"1036600163","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1191944764","pubTimestamp":1760965814,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Stock News","introduction":"Global Stock News First-Time Broadcast","home_visible":1,"id":"1036600163","head_image":"https://community-static.tradeup.com/news/b3bf6d02ad1a6e9e7377eebbb162346a"},"summary":"On October 20, Roche Holding Ltd (RHHBY.US) announced that ocrelizumab (marketed as Gazyva/Gazyvaro) has received FDA approval for a new indication to treat adult patients with active lupus nephritis...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","RHHBY":"罗氏控股","03165":"华夏欧优股对冲"},"translate_title":"罗氏控股有限公司(RHHBY.US)Ocrelizumab治疗狼疮性肾炎获批","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"03165":1,"RHHBY":1},"content_text":"On October 20, Roche Holding Ltd (RHHBY.US) announced that ocrelizumab (marketed as Gazyva/Gazyvaro) has received FDA approval for a new indication to treat adult patients with active lupus nephritis (LN) who are receiving standard therapy. After an initial treatment consisting of four doses in the first year, the dosing frequency can be modified to twice a year. This drug is the first CD20-targeted therapy approved by the FDA for the treatment of lupus nephritis. The FDA's decision was primarily based on positive results from the Phase II NOBILITY study and the Phase III REGISTRY study. The REGISTRY study demonstrated that 46.4% of patients treated with ocrelizumab in combination with standard therapy (mycophenolate mofetil and corticosteroids) achieved complete renal response (CRR) at week 76, compared to 33.1% in the standard therapy group (adjusted difference of 13.4%, 95% CI: 2.0%-24.8%; P=0.0232). Additionally, the ocrelizumab group showed clinically meaningful improvements in complement levels, as well as reductions in anti-dsDNA antibodies, disease activity, and inflammation markers.","kind":"news","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,"need_auth":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,"deviceId":"web-server-community-laohu8-v3","version":"4.35.9","shortVersion":"4.35.9","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/1191944764","isCrawlerRequest":true}