FDA拒绝将Pharming公司的Ruconest用于预防遗传性血管性水肿

2018-09-23 MedSci MedSci原创

美国监管机构拒绝了Pharming公司的申请:将Ruconest的治疗范围扩大到预防遗传性血管性水肿(HAE)。美国食品和药物管理局(FDA)的完整回应函(CRL)要求其进行额外的临床试验,以进一步评估药物在这种情况下的有效性。

美国监管机构拒绝了Pharming公司的申请:将Ruconest的治疗范围扩大到预防遗传性血管性水肿(HAE)。美国食品和药物管理局(FDA)的完整回应函(CRL)要求其进行额外的临床试验,以进一步评估药物在这种情况下的有效性。

Pharming首席运营官Bruno Giannetti博士说:"虽然结果不是我们预期的,但我们期待与FDA合作,补充额外的临床数据,以便患者能够使用Ruconest预防HAE。"

该公司首席执行官Sijmen de Vries表示:"我们认为这是一个小小的挫折......我们将继续开发创新的以及更便捷的Ruconest给药方式,用于急性治疗和预防HAE。"

Ruconest于2010年在欧洲首次被获准用于治疗罕见的遗传性疾病HAE。HAE是由一种叫做 C1 酯酶抑制剂的血浆蛋白数量不足引起,在美国这种疾病影响大约 6000 至 1 万名患者。患有 HAE 的人可迅速发生快速的手、脚、四肢、脸、肠道或呼吸道肿胀。这些肿胀的急性发作可自然而然发生,或通过压力、手术或感染诱发产生。呼吸道肿胀在不及时治疗的情况下可能会是致命的。Ruconest 是从转基因兔子的奶中纯化的一种人重组 C1 酯酶抑制剂。Ruconest 旨在恢复患者血浆中功能性 C1 酯酶抑制剂的水平,从而治疗这种肿胀的急性发作。

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    2018-09-30 jj000001
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  5. 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createdTime=Mon Sep 24 07:54:49 CST 2018, time=2018-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=346368, encodeId=9ca93463688f, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Mon Sep 24 07:34:40 CST 2018, time=2018-09-24, status=1, ipAttribution=)]
    2019-03-16 liao1619
  6. 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createdAvatar=null, createdBy=9c785304850, createdName=guoyibin, createdTime=Tue Sep 25 12:30:00 CST 2018, time=2018-09-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=346390, encodeId=8571346390fc, content=嗯嗯,学习学习。, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/07/16/3b24606172648eea459125cb74754afe.jpg, createdBy=6c022216608, createdName=liumin1987, createdTime=Mon Sep 24 09:06:52 CST 2018, time=2018-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=346383, encodeId=de20346383f1, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Mon Sep 24 07:54:49 CST 2018, time=2018-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=346368, encodeId=9ca93463688f, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Mon Sep 24 07:34:40 CST 2018, time=2018-09-24, status=1, ipAttribution=)]
    2018-09-25 小华子
  7. 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  8. 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createdTime=Mon Sep 24 07:54:49 CST 2018, time=2018-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=346368, encodeId=9ca93463688f, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Mon Sep 24 07:34:40 CST 2018, time=2018-09-24, status=1, ipAttribution=)]
    2018-09-24 liumin1987

    嗯嗯,学习学习。

    0

  9. 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createdTime=Mon Sep 24 07:54:49 CST 2018, time=2018-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=346368, encodeId=9ca93463688f, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Mon Sep 24 07:34:40 CST 2018, time=2018-09-24, status=1, ipAttribution=)]
    2018-09-24 orangesking

    0

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createdTime=Mon Sep 24 07:54:49 CST 2018, time=2018-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=346368, encodeId=9ca93463688f, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Mon Sep 24 07:34:40 CST 2018, time=2018-09-24, status=1, ipAttribution=)]
    2018-09-24 明月清辉

    谢谢分享,学习了

    0