Pfizer Voluntarily Withdraws Sickle Cell Disease Treatment Oxbryta From Global Market Due To Painful Disease Complication, Deaths

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Pfizer Voluntarily Withdraws Sickle Cell Disease Treatment Oxbryta From Global Market Due To Painful Disease Complication, Deaths

Benzinga09-26

On Wednesday, Pfizer Inc. (NYSE:PFE) said the company is voluntarily withdrawing all lots of Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) at this time, in all markets where it is...

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(NYSE:PFE) said the company is voluntarily withdrawing all lots of Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) at this time, in all markets where it is...</p>\n\n<a href=\"https://finance.yahoo.com/news/pfizer-voluntarily-withdraws-sickle-cell-142908513.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":"LU1066051498.USD","symbol_name":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","start_time":0,"source_url":"https://finance.yahoo.com/news/pfizer-voluntarily-withdraws-sickle-cell-142908513.html","article_id":"2470753581","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2470753581","pubTimestamp":1727360948,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"On Wednesday, Pfizer Inc.  said the company is voluntarily withdrawing all lots of Oxbryta for the treatment of sickle cell disease  at this time, in all markets where it is approved.Pfizer is also discontinuing all active voxelotor clinical trials and expanded access programs worldwide.Pfizer’s decision is based on the totality of clinical data indicating that the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population.Also Read: FDA Battles Backlog of Drug Factory Inspections Since COVID-19.The data suggest an imbalance in vaso-occlusive crises and fatal events that require further assessment.A vaso-occlusive crisis is a common painful complication of sickle cell anemia.Pfizer has notified regulatory authorities about these findings and its decision to voluntarily withdraw Oxbryta from the market and discontinue distribution and clinical studies while further reviewing the available data and investigating the findings.In the second quart","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","LU1066053197.SGD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM3\" (SGDHDG) INC","BK4588":"碎股","SG9999002224.SGD":"Allianz Global High Payout SGD","BK4550":"红杉资本持仓","BK4568":"美国抗疫概念","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","LU0122379950.USD":"贝莱德世界健康科学A2","IE000M9KFDE8.USD":"NEUBERGER BERMAN US LARGE CAP VALUE \"A\" (USD) ACC","LU0225284248.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" ACC","PFE":"辉瑞","LU0058720904.USD":"联博国际健康护理基金A","BK4581":"高盛持仓","SG9999001176.USD":"United Global Healthcare Acc USD","LU1894683348.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) INC","IE00BLSP4452.SGD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis SGD-H Plus","IE00BLSP4239.USD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis USD Plus","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","LU0306807586.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" (USD) INC QF","SG9999003800.SGD":"Nikko AM Global Dividend Equity Acc SGD-H","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","LU0225771236.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (USD) INC MF","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H","LU1883839398.USD":"AMUNDI FUNDS INCOME OPPORTUNITIES \"A2\" (USD) ACC","LU0170899867.USD":"EASTSPRING INVESTMENTS WORLD VALUE EQUITY  \"A\" (USD) ACC","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","BK4592":"伊斯兰概念","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","BK4585":"ETF&股票定投概念","SCD":"LMP Capital & Income Fund","SG9999011175.SGD":"Nikko AM Global Dividend Equity Dis SGD-H","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","LU0321505868.SGD":"Schroder ISF Global Dividend Maximiser A Dis SGD","BK4534":"瑞士信贷持仓","SG9999002232.USD":"Allianz Global High Payout USD","LU0234572021.USD":"高盛美国核心股票组合Acc","LU0321505439.SGD":"Schroder ISF Global Dividend Maximiser A Acc SGD","BK4007":"制药","BK4533":"AQR资本管理(全球第二大对冲基金)","LU0985481810.HKD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (HKD) INC M","LU0306806265.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" ACC","LU1894683264.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) ACC"},"translate_title":"由于痛苦的疾病并发症、死亡，辉瑞自愿从全球市场撤回镰状细胞病治疗药物Oxbryta","themeId":"693c6351429fb5f70a8db1794ff96fa6","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SCD":1,"PFE":1},"content_text":"On Wednesday, Pfizer Inc. (NYSE:PFE) said the company is voluntarily withdrawing all lots of Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) at this time, in all markets where it is approved.\nPfizer is also discontinuing all active voxelotor clinical trials and expanded access programs worldwide.\nPfizer’s decision is based on the totality of clinical data indicating that the overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient population.\nAlso Read: FDA Battles Backlog of Drug Factory Inspections Since COVID-19.\nThe data suggest an imbalance in vaso-occlusive crises and fatal events that require further assessment.\nA vaso-occlusive crisis is a common painful complication of sickle cell anemia.\nPfizer has notified regulatory authorities about these findings and its decision to voluntarily withdraw Oxbryta from the market and discontinue distribution and clinical studies while further reviewing the available data and investigating the findings.\nThe company does not anticipate the event impacting its full-year 2024 financial guidance.\nIn the second quarter of 2024, Oxbryta generated sales of $92 million, up 20% year-over-year. Pfizer added Oxbryta to its portfolio via its $5.4 billion buyout of Global Blood Therapeutics in 2022.\nIn July, the European Medicines Agency (EMA) initiated a review of Oxbryta (voxelotor) following clinical trial data indicating a higher number of deaths in patients receiving Oxbryta compared to those on a placebo. Another trial also reported more deaths than expected overall.\nOne trial focused on patients with sickle cell disease who were at increased risk of stroke, while the other studied the drug’s impact on leg ulcers, a common complication of the condition.\nThe manufacturer has now halted Oxbryta treatment in both trials, which are pending further investigation.\nIn November 2019, the FDA granted accelerated approval to voxelotor (Oxbryta) for adults and pediatric patients 12 years of age and older with sickle cell disease.\nPrice Action: PFE stock is down 0.54% at $28.78 at the last check on Thursday.\nRead Next:\n\nEXCLUSIVE: Vivani Medical Advances Its Obesity Treatment Implant With New Clinical Trial in Australia.\n\nUp Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market.\nGet the latest stock analysis from Benzinga?\n\nPFIZER (PFE): Free Stock Analysis Report\n\nThis article Pfizer Voluntarily Withdraws Sickle Cell Disease Treatment Oxbryta From Global Market Due To Painful Disease Complication, Deaths originally appeared on Benzinga.com\n© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-2","news_tag":"Product Release","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"hasMoreComments":false,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false}}