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FDA批准**一款治疗非透析慢性肾病患者缺铁性贫血片剂

2017-11-08 编译/David 新浪医药新闻

11月7日,致力于肾疾病治疗创新药物开发的Keryx Biopharmaceuticals表示,美国FDA批准了公司Auryxia(柠檬酸铁)一项新的适应症申请,这项被批准的新适应症为用于未进行透析治疗的慢性肾病成年患者缺铁性贫血的治疗。Auryxia最初于2014年9月被批准治疗需要接受透析治疗的慢性肾病患者血磷水平的控制。

11月7日,致力于肾疾病治疗创新药物开发的Keryx Biopharmaceuticals表示,美国FDA批准了公司Auryxia(柠檬酸铁)一项新的适应症申请,这项被批准的新适应症为用于未进行透析治疗的慢性肾病成年患者缺铁性贫血的治疗。Auryxia最初于2014年9月被批准治疗需要接受透析治疗的慢性肾病患者血磷水平的控制。



随着这次新的适应症获批,将会有上百万的更多慢性肾病患者从Auryxia治疗中获益。该款药物在药店可以获得并且已被医疗保险D部分和美国的商业保险商广泛覆盖。

纽约Great Neck的Northwell Health肾病及高血压部门的Steven Fishbane博士表示:“美国3000万慢性肾病患者中大约一半同时伴有缺铁症状,Auryxia是目前为止唯一一个获批的专用于未接受透析治疗的慢性肾病患者缺铁性贫血的片剂药物。从今天开始,临床医生将可以处方该款口服铁剂帮助绝大多数并未得到最佳医治的病患改善病情。”

Keryx高级副总裁及首席医学官John Neylan博士表示:“对于更广泛的适应症获得了FDA的认可我们感到非常高兴,该药物将作为一线治疗选择用于慢性肾病及缺铁性贫血成人患者的治疗。”

Auryxia这次补充新药申请的获批是基于一项为期24周、安慰剂对照、在234名非透析依赖性慢性肾病成年患者中开展的临床3期试验的结果。入组这项研究的患者的血红蛋白水平应在9.0 g/dL到11.5 g/dL之间,且对之前的补铁治疗不耐受或治疗不佳。试验中的起始剂量为每天3片餐时用药,研究中每天的平均用药为5片。重要的是,在治疗期间入组患者不允许接受其他的口服或注射铁剂以及红细胞生成刺激剂的补充。

研究结果显示,对于大多数患者(52.1 %, n=61/117,相较于安慰剂组的19.1 %, n=22/115)在16周疗效期内的任一时间点,通过Auryxia用药均可以获得>1 g/dL血红蛋白水平的显着升高,这是具有显着临床意义的结果。

在此研究中,柠檬酸铁总体耐受性良好,不良事件也与柠檬酸铁的已知副作用相一致。这项3期研究中的最常见的不良事件及发生率分别为腹泻(21%)、便秘(19%)、粪便变色(15%)、恶心(11%)、腹痛(6%)及高血钾(7%),这些结果已经在线发表在2017年1月的《Journal of the American Society of Nephrology》(JASN)。

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    2017-11-08 中医痴

    不错了.学习了.谢谢分享!

    0

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