美国FDA批准PANZYGA治疗成人慢性炎性脱髓鞘性多发性神经病(CIDP)

2021-02-14 Allan MedSci原创

慢性炎症性脱髓鞘性多发性神经病(chronic inflammatory demyelinating polyneuropathy,CIDP)是一种周围神经和神经根的获得性疾病。

慢性炎症性脱髓鞘性多发性神经病(chronic inflammatory demyelinating polyneuropathy,CIDP)是一种周围神经和神经根的获得性疾病。其特征是对称运动的逐渐增加、感觉丧失以及与深层腱反射丧失相关的无力。CIDP是由称为髓磷脂的神经覆盖层受损引起的,CIDP的逐渐发作可将诊断延迟数月甚至数年,从而导致严重的神经损伤,从而可能限制并延迟对治疗的反应。大多数患者需要长期治疗;如果不及时治疗,近三分之一的CIDP患者将发展为轮椅依赖性。早期识别和适当治疗对于避免残疾是至关重要的。

辉瑞公司今天宣布,美国食品药品监督管理局(FDA)已批准PANZYGA®的补充生物制剂许可申请(sBLA),以允许其治疗CIDP成人患者。PANZYGA可以高达12 mg / kg / min的输注速度给药。

辉瑞公司医院业务部门全球总裁Angela Lukin说:“每位CIDP患者都有不同的治疗需求,我们发现拥有一个批准的剂量选择并不总是最佳选择。该新适应症的批准能够使医疗保健提供者选择适合患者的批准剂量,这将有助于满足未满足的患者需求”。

 

原始出处:

https://www.firstwordpharma.com/node/1800643?tsid=4

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    2021-07-10 bugit
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    2021-03-05 jml2009
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likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210213/f6efe772e64a4d43a4f84fa895d5563e/03b3c2b9f0cd4e128f02dd2ffc620743.jpg, createdBy=897d1605912, createdName=zhangwangwei, createdTime=Sat Jun 12 15:54:04 CST 2021, time=2021-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=973063, encodeId=e46e9e3063ef, content=实用,谢谢🙏, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210213/f6efe772e64a4d43a4f84fa895d5563e/03b3c2b9f0cd4e128f02dd2ffc620743.jpg, createdBy=897d1605912, createdName=zhangwangwei, createdTime=Sat Jun 12 15:51:43 CST 2021, time=2021-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1491396, encodeId=8ae5149139649, content=<a href='/topic/show?id=5316e4387aa' target=_blank style='color:#2F92EE;'>#神经病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74387, encryptionId=5316e4387aa, topicName=神经病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Tue Feb 16 11:53:01 CST 2021, time=2021-02-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1516414, encodeId=b7dc151641494, content=<a href='/topic/show?id=8160852e55c' target=_blank style='color:#2F92EE;'>#脱髓鞘#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85275, encryptionId=8160852e55c, topicName=脱髓鞘)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f3ba10959947, createdName=1696533704_45270457, createdTime=Tue Feb 16 11:53:01 CST 2021, time=2021-02-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551508, encodeId=cd6615515083e, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Tue Feb 16 11:53:01 CST 2021, time=2021-02-16, status=1, ipAttribution=)]
  5. 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likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210213/f6efe772e64a4d43a4f84fa895d5563e/03b3c2b9f0cd4e128f02dd2ffc620743.jpg, createdBy=897d1605912, createdName=zhangwangwei, createdTime=Sat Jun 12 15:54:04 CST 2021, time=2021-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=973063, encodeId=e46e9e3063ef, content=实用,谢谢🙏, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210213/f6efe772e64a4d43a4f84fa895d5563e/03b3c2b9f0cd4e128f02dd2ffc620743.jpg, createdBy=897d1605912, createdName=zhangwangwei, createdTime=Sat Jun 12 15:51:43 CST 2021, time=2021-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1491396, encodeId=8ae5149139649, content=<a href='/topic/show?id=5316e4387aa' target=_blank style='color:#2F92EE;'>#神经病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74387, encryptionId=5316e4387aa, topicName=神经病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Tue Feb 16 11:53:01 CST 2021, time=2021-02-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1516414, encodeId=b7dc151641494, content=<a href='/topic/show?id=8160852e55c' target=_blank style='color:#2F92EE;'>#脱髓鞘#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85275, encryptionId=8160852e55c, topicName=脱髓鞘)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f3ba10959947, createdName=1696533704_45270457, createdTime=Tue Feb 16 11:53:01 CST 2021, time=2021-02-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551508, encodeId=cd6615515083e, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Tue Feb 16 11:53:01 CST 2021, time=2021-02-16, status=1, ipAttribution=)]
    2022-01-28 xlxchina
  6. 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href='/topic/show?id=5316e4387aa' target=_blank style='color:#2F92EE;'>#神经病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74387, encryptionId=5316e4387aa, topicName=神经病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Tue Feb 16 11:53:01 CST 2021, time=2021-02-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1516414, encodeId=b7dc151641494, content=<a href='/topic/show?id=8160852e55c' target=_blank style='color:#2F92EE;'>#脱髓鞘#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85275, encryptionId=8160852e55c, topicName=脱髓鞘)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f3ba10959947, createdName=1696533704_45270457, createdTime=Tue Feb 16 11:53:01 CST 2021, time=2021-02-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551508, encodeId=cd6615515083e, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Tue Feb 16 11:53:01 CST 2021, time=2021-02-16, status=1, ipAttribution=)]
    2021-06-12 zhangwangwei

    非常实用和好用的临床指南,感谢梅斯医学给提供的平台

    0

  7. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551508, encodeId=cd6615515083e, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Tue Feb 16 11:53:01 CST 2021, time=2021-02-16, status=1, ipAttribution=)]
    2021-06-12 zhangwangwei

    实用,谢谢🙏

    0

  8. 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