FDA Flags Deadly Risks, AstraZeneca Pulls Andexxa From US Market

Benzinga12-22 22:45

The U.S. Food and Drug Administration (FDA) said the safety risks associated with Andexxa now outweigh its benefits, prompting AstraZeneca Plc (NASDAQ:AZN) to seek a voluntary withdrawal of the drug’s...

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The FDA on Thursday said it reviewed postmarketing safety data showing thromboembolic events, including serious and fatal cases, in patients treated with Andexxa.In response, the company requested to voluntarily withdraw the biologics license application for commercial reasons and confirmed it will end U.S. commercial sales by Dec. 22, 2025.AstraZeneca said Andexxa will no longer be manufactured for or sold in the","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","BK4007":"制药","LU2417539215.USD":"ALLIANZ GLOBAL INCOME \"AMF\" (USD) INC","LU2236285917.USD":"ALLIANZ GLOBAL INCOME \"AMG\" (USD) INC","BK4588":"碎股","AZN":"阿斯利康","BK4568":"美国抗疫概念","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","LU2462157665.USD":"ALLIANZ GLOBAL INCOME \"A\" (USD) INC","BK4585":"ETF&股票定投概念","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU1829250122.USD":"高盛欧洲核心股票组合Acc","LU2456880835.USD":"ALLIANZ GLOBAL INCOME \"AT\" (USD) ACC"},"translate_title":"FDA标记致命风险，阿斯利康从美国市场撤出Andexxa","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AZN":1},"content_text":"The U.S. Food and Drug Administration (FDA) said the safety risks associated with Andexxa now outweigh its benefits, prompting AstraZeneca Plc (NASDAQ:AZN) to seek a voluntary withdrawal of the drug’s biologics license and plan an exit from the U.S. market.\nIn November 2024, the Cellular, Tissue, and Gene Therapies Advisory Committee discussed a supplemental biologics license application for Andexxa.\nBefore the meeting, the FDA panel released brief documents highlighting some safety issues and other concerns.\nAlso Read: Drugmakers Briefed As Vaccine Skeptics Like RFK Jr. Probe RSV Therapy Risks\nThe FDA on Thursday said it reviewed postmarketing safety data showing thromboembolic events, including serious and fatal cases, in patients treated with Andexxa.\nBased on this evidence, the agency concluded that the product’s risk profile is no longer favorable and communicated its position to AstraZeneca.\nIn response, the company requested to voluntarily withdraw the biologics license application for commercial reasons and confirmed it will end U.S. commercial sales by Dec. 22, 2025.\nAstraZeneca said Andexxa will no longer be manufactured for or sold in the U.S. after that date.\nAndexxa received accelerated approval in 2018 as a recombinant modified human factor Xa protein designed to reverse anticoagulation in patients treated with rivaroxaban or apixaban who experience life-threatening or uncontrolled bleeding.\nAt approval, the product carried a boxed warning highlighting thromboembolic risks.\nThe accelerated approval was based on reductions in anti–factor Xa activity, a surrogate endpoint considered reasonably likely to predict clinical benefit.\nAs a condition of approval, AstraZeneca was required to conduct a randomized controlled trial to confirm clinical benefit in patients with intracerebral hemorrhage.\nThat requirement was addressed through the ANNEXA-I trial, results of which were submitted in a supplemental biologics license application in January 2024. The FDA later convened an advisory committee meeting in November 2024 to review the findings.\nData from the trial showed a higher rate of thrombosis in patients treated with Andexxa compared with usual care, including more thrombosis-related deaths by Day 30.\nMore than half of the thrombotic events in the Andexxa arm occurred earlier than those observed in the control group.\nAZN Price Action: AstraZeneca shares were down 0.28% at $91.10 at the time of publication on Monday. The stock is approaching its 52-week high of $94.01, according to Benzinga Pro data.\nRead Next:\nPhoto by Robert Way via Shutterstock","kind":"news","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":"4.35.12","shortVersion":"4.35.12","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/2593435292","isCrawlerRequest":true}