[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"content-doc-dcio7aec8a28":3},{"user":4,"document":8,"mainDocument":27,"columnUrl":29,"subscription":30,"footer":42,"text":77},{"isAuthenticated":5,"isAdmin":5,"displayName":6,"avatarUrl":6,"nid":6,"groupLevel":7},false,"",-10,{"id":9,"fullTitle":10,"subTitle":6,"url":11,"columnId":12,"columnName":13,"columnUrl":14,"summary":6,"contentHtml":15,"mainContentHtml":6,"posterUrl":16,"createDate":17,"displayDate":18,"displayDateSlash":19,"pageviews":20,"tags":21,"hidden":5,"isSubContent":5,"replyDocOrTargetId":6,"contentType":23,"videoId":6,"liveVideoUrl":6,"duration":24,"price":24,"priceText":25,"priceBadgeText":25,"priceBadgeClass":26,"freeForMinGroupLevel":24,"redirectUrl":6,"readyToStream":5},"dcio7aec8a28","安进(AMGN)聘请杜克临床研究所独立复核-力保明星药Tavneos免于退市","\u002Fdoc\u002Fdcio7aec8a28","col18178739ee","美股资讯","\u002Fcol\u002Fcol18178739ee","\u003Cp>\r\n\u003Cp>\u003Cspan style=\"font-size: large;\">美股投资网获悉，在美国食品药品监督管理局(FDA)以数据操纵和安全性问题为由提议将罕见病药物Tavneos撤出市场后，安进(AMGN)已聘请杜克临床研究所(Duke Clinical Research Institute)对关键临床数据进行独立重新评估，试图为这款年销售额约5亿美元的产品争取转机。\u003C\u002Fspan>\u003C\u002Fp>\r\n\u003Cp>\u003Cspan style=\"font-size: large;\">安进在6月1日致FDA药品评价与研究中心的一封信中披露了这一安排，该信函于本周四在监管机构网站上公开。信中提到，杜克临床研究所自今年2月起，已启动一项“独立且完全设盲的重新裁定”，针对支持Tavneos获批的ADVOCATE后期临床研究的主要终点结果进行复核。安进计划最晚于6月29日向FDA提交重新分析后的详细数据，作为证明药物获益大于风险的支撑材料。\u003C\u002Fspan>\u003C\u002Fp>\r\n\u003Cp>\u003Cspan style=\"font-size: large;\">据了解，Tavneos(通用名avacopan)于2021年10月获FDA批准，用于治疗严重活动性抗中性粒细胞胞浆抗体(ANCA)相关性血管炎，这是一种可导致小血管炎症、进而严重损伤肾脏和肺部的罕见自身免疫性疾病。安进在2022年以37亿美元收购ChemoCentryx时获得了该药，目前年销售额约5亿美元。\u003C\u002Fspan>\u003C\u002Fp>\r\n\u003Cp>\u003Cspan style=\"font-size: large;\">今年4月，FDA正式提议撤回Tavneos的批准，理由包括原始申报材料中存在虚假陈述，药物有效性未能得到充分证实，以及一系列安全性信号。根据FDA药物评价与研究中心的信息，监管机构已确认76例与Tavneos相关的严重药物性肝损伤，其中包含8例死亡，部分病例还出现了严重的胆管消失综合征。更早之前，FDA曾表示，任何针对Tavneos数据的新独立分析在统计学上均不合适，也无法“挽救”这项已受质疑的研究。\u003C\u002Fspan>\u003C\u002Fp>\r\n\u003Cp>\u003Cspan style=\"font-size: large;\">安全性担忧不仅限于美国。安进在日本的市场合作伙伴Kissei Pharmaceutical今年5月发布的安全通知显示，日本已有约20名接受Tavneos治疗的患者死于严重肝功能障碍，不过目前尚不能明确药物在其中的具体作用。此外，最初发表ADVOCATE研究结果的医学期刊也已就数据操纵指控展开独立调查。\u003C\u002Fspan>\u003C\u002Fp>\r\n\u003Cp>\u003Cspan style=\"font-size: large;\">面对重重质疑，安进在信中强调，公司认为Tavneos的获益大于风险，将药物撤市“不符合患者的最佳利益”。安进发言人回应称，公司将仔细审视杜克研究所的审查结果，并继续与监管机构、研究人员和医疗界保持适当沟通。杜克临床研究所则对此拒绝置评。\u003C\u002Fspan>\u003C\u002Fp>\r\n\u003Cp>\u003Cspan style=\"font-size: large;\">最专业的美股资讯,推荐美股大数据 \u003Ca href=\"https:\u002F\u002FStockwe.com\u002F\">https:\u002F\u002FStockwe.com\u002F\u003C\u002Fa>\u003C\u002Fspan>\u003C\u002Fp>\r\n\u003Cp>\u003Cspan style=\"font-size: large;\">如何识别美股市场异常波动？美国机构主力资金买卖情况，出货和吸筹，使用美股投资网VIP会员，2008年成立于美国硅谷，由前纽约证券交易所分析师Ken创立，联合多位摩根斯坦利分析师，谷歌 Meta工程师利用AI和大数据，配合十多年美股实战经验和业内量化模型，建立了一个股市数据库 \u003Ca href=\"https:\u002F\u002FStockWe.com\u002F\">https:\u002F\u002FStockWe.com\u002F\u003C\u002Fa> 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buy@TradesMax.com 美国电话 626-378-3637","公司介绍","\u003Cp class=\"MsoNormal\">美股大数据 StockWe.com 是一个美国领先的金融和美股信息大数据提供商，紧盯华尔街金融市场和行情，2008年成立于美国硅谷，创始人是前纽约证券交易所资深分析师Ken，联合多位摩根斯坦利分析师，谷歌 Meta工程师利用AI和大数据，配合十多年美股实战经验和业内量化交易模型，每天处理千万级股票数据：挖掘潜力大牛股，捕捉期权异动大单，实时主力资金流向、机构持仓变化、川普突发新闻，精准买卖信号第一时间发到您手机APP。\u003C\u002Fp>","专业美股投资者都在这里",{"loading":78,"search":79,"searchPlaceholder":79,"hotContent":80,"draft":81,"noData":82,"searchNoData":83,"edit":84,"editVideo":85,"courseContent":86,"more":87,"buyNow":88,"subscribeNow":89,"encoding":90,"paidContent":91},"Loading...","搜索","热门内容","草稿","目前没有任何内容公布","当前检索内容没有数据","编辑","编辑视频","课程内容","更多","立即购买后观看","- 立即订阅 -","视频编码中...","付费内容"]