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FDA推迟雅培阿达木单抗(Humira)新适应症决定

2012-05-24 potato 生物谷

2012年5月23日,FDA将雅培(Abbott)公司畅销药物阿达木单抗(Humira)结肠炎新适应症(溃疡性结肠炎)的决定推迟了数月,并要求雅培提供更多的信息。雅培预计在今年年底能得到FDA的决定。 溃疡性结肠炎(ulcerative colitis)是由一种未知的免疫系统问题引发的大肠及直肠炎症,能够导致腹痛、便血及体重减轻。根据美国克罗恩病及溃疡性结肠炎基金会(Crohn's &

2012年5月23日,FDA将雅培(Abbott)公司畅销药物阿达木单抗(Humira)结肠炎新适应症(溃疡性结肠炎)的决定推迟了数月,并要求雅培提供更多的信息。雅培预计在今年年底能得到FDA的决定。

溃疡性结肠炎(ulcerative colitis)是由一种未知的免疫系统问题引发的大肠及直肠炎症,能够导致腹痛、便血及体重减轻。根据美国克罗恩病及溃疡性结肠炎基金会(Crohn's & Colitis Foundation of America)数据,在美国约有50万溃疡性结肠炎患者,这将成为Humira巨大的新市场。

FDA暂缓Humira新适应症决定的时间不是很理想:雅培正在筹备将其制药单元分拆成一个名为AbbVie的新公司。而新公司的基石便是Humira,该药在2011年的销售额达79亿美元,因此,在首次公开招股(IPO)时,Humira的前景越大越好。分析家曾预测,结肠炎新适应症将使Humira在2012年的销售额达90亿美元。此外,Humira专利在2016年到期,雅培/AbbVie需要抓紧时间捕获尽可能多的收入。

Humira不会独享结肠炎市场。此前,强生(Johnson & Johnson)公司药物Remicade已被批准用于一线药物治疗失败的结肠炎患者。同时,强生公司正在开发Remicade的后继者Simponi,用于溃疡性结肠炎的治疗。该公司刚刚公布了一项新研究的结果,数据表明,经标准治疗失败的患者,接受Simponi治疗后大多数患者的症状得到了缓解,而安慰剂组为29%。(生物谷bioon.com)

编译自:FiercePharma
http://www.fiercepharma.com/story/new-use-humira-delayed-abbott-preps-spinoff/2012-05-23

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    2013-04-08 smallant2002
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    2012-05-26 zhouqu_8
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