FDA Flags Antibody Risk After Child's Death Linked To Takeda's Enzyme Replacement Therapy For Rare Blood Disorder

Benzinga_recent_news11-22

The U.S. Food and Drug Administration (FDA) on Friday said it has received postmarketing reports of neutralizing antibodies to ADAMTS13 in patients treated with Adzynma (recombinant ADAMTS13), ...

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/2585128462?lang=en_US&edition=fundamental","thumbnail":"https://cdn.benzinga.com/files/images/story/2025/11/21/Motala--Sweden--7-January-2023-Fda-Logo-.jpeg?optimize=medium&dpr=2&auto=webp&width=240","is_english":true,"pubTime":"2025-11-22 02:43","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2585128462","market":"us","top_or_hot":-1,"title":"FDA Flags Antibody Risk After Child's Death Linked To Takeda's Enzyme Replacement Therapy For Rare Blood Disorder","media":"Benzinga_recent_news","content":"<div>\n<p>The U.S. Food and Drug Administration (FDA) on Friday said it has received postmarketing reports of neutralizing antibodies to ADAMTS13 in patients treated with Adzynma (recombinant ADAMTS13), ...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/25/11/49012169/fda-flags-antibody-risk-after-childs-death-linked-to-takedas-enzyme-replacement-therapy-for-rare-blood-disorder\">Source Link</a>\n\n</div>\n","source":"benzinga_recent_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>FDA Flags Antibody Risk After Child's Death Linked To Takeda's Enzyme Replacement Therapy For Rare Blood Disorder</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\">\nFDA Flags Antibody Risk After Child's Death Linked To Takeda's Enzyme Replacement Therapy For Rare Blood Disorder\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-11-22 02:43 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.benzinga.com/news/fda/25/11/49012169/fda-flags-antibody-risk-after-childs-death-linked-to-takedas-enzyme-replacement-therapy-for-rare-blood-disorder><strong>Benzinga_recent_news</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>The U.S. Food and Drug Administration (FDA) on Friday said it has received postmarketing reports of neutralizing antibodies to ADAMTS13 in patients treated with Adzynma (recombinant ADAMTS13), ...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/25/11/49012169/fda-flags-antibody-risk-after-childs-death-linked-to-takedas-enzyme-replacement-therapy-for-rare-blood-disorder\">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":"BK4007","symbol_name":"制药","start_time":0,"source_url":"https://www.benzinga.com/news/fda/25/11/49012169/fda-flags-antibody-risk-after-childs-death-linked-to-takedas-enzyme-replacement-therapy-for-rare-blood-disorder","article_id":"2585128462","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2025/11/21/Motala--Sweden--7-January-2023-Fda-Logo-.jpeg?optimize=medium&dpr=2&auto=webp&width=240"],"rights":{"source":"benzinga_recent_news","url":"https://www.benzinga.com/news/fda/25/11/49012169/fda-flags-antibody-risk-after-childs-death-linked-to-takedas-enzyme-replacement-therapy-for-rare-blood-disorder","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2585128462","pubTimestamp":1763750580,"columns":[],"sourceInfo":{"source_id":"benzinga_recent_news","name":"Benzinga"},"weMediaInfo":null,"summary":"FDA reports rare neutralizing antibodies, including a pediatric death, in patients treated with Takeda's Adzynma for congenital TTP.","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","TAK":"武田制药"},"translate_title":"FDA在儿童死亡与武田治疗罕见血液疾病的酶替代疗法有关后标记抗体风险","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"TAK":1},"content_text":"The U.S. Food and Drug Administration (FDA) on Friday said it has received postmarketing reports of neutralizing antibodies to ADAMTS13 in patients treated with Adzynma (recombinant ADAMTS13), including one pediatric death.\nTakeda Pharmaceutical Co., Ltd. (NYSE:TAK) Adzynma is approved as a prophylactic or on-demand enzyme replacement therapy for congenital thrombotic thrombocytopenic purpura (cTTP) and contains two rADAMTS13 variants—one native and one with a single amino-acid modification.\nA genetic mutation causes cTTP, which is a rare disorder.\nAlso Read: Takeda Lowers 2025 Outlook After Weak Q2 And Pipeline Impairment Charges\nFor reference, ADAMTS13 is a key regulator of blood clotting, preventing excessive clot formation in normal circulation.\nIts primary function is to cleave vWF, a large protein that helps platelets clump together to form clots.\nBy cutting large vWF into smaller pieces, ADAMTS13 prevents platelets from clumping together unnecessarily, which helps avoid abnormal blood clots.\nThe reported fatality involved a child with a history of severe allergic reactions to fresh frozen plasma.\nThe patient developed neurologic symptoms and was found to have neutralizing antibodies about 10 months after initiating prophylactic Adzynma.\nCurrent assays cannot distinguish antibodies targeting the recombinant enzyme from those against endogenous ADAMTS13.\nAdzynma's U.S. label already flags the potential for neutralizing antibody development under \"Immunogenicity,\" and the Patient Package Insert advises monitoring for inhibitors.\nNo neutralizing antibodies were reported during clinical trials, and the label does not yet reflect the postmarketing cases tied to serious or fatal outcomes.\nPrice Action: TAK stock is up 1.88% at $14.33 at the last check on Friday.\nRead Next:\nImage: Shutterstock","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-2","news_tag":"policyRegulatory","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":"4.35.10","shortVersion":"4.35.10","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/2585128462","isCrawlerRequest":true}