血液科

订阅

MedSci主页 / 所有栏目 / 血液科

拜耳旗下Jivi获得欧盟批准用于治疗及预防A型血友病

2018-11-28 MedSci MedSci原创

A型血友病拜耳Jivi
关注

拜耳制药近日表示，欧盟委员会已经批准重组因子VIII（rFVIII）替代疗法Jivi（BAY94-9027）用于治疗和预防12岁或以上的A型血友病。

血友病多数是遗传性疾病，造成人体无法凝血来止血，致使病人受伤后流血时间更长，并增加关节或脑出血的机率。血友病可以分为两种主要类型，A型血友病为缺乏第8凝血因子，B型血友病为缺乏第9凝血因子。

拜耳制药近日表示，欧盟委员会已经批准重组因子VIII（rFVIII）替代疗法Jivi（BAY94-9027）用于治疗和预防12岁或以上的A型血友病。Jivi（BAY94-9027）在今年8月于美国获批，在今年9月于日本获批，在今年10月于加拿大获批。根据拜耳的说法，欧洲的批准得到了PROTECT VIII试验数据的支持，该试验对先前经过治疗的成人和至少12岁患有严重A型血友病的儿童进行了研究。研究结果表明，74％的患者每周接受一剂Jivi，并且所有每五天接受一次药物的患者都表现出良好的出血保护，每周一次的出血率仅为0.96。


原始出处：

http://www.firstwordpharma.com/node/1607268#axzz5Y7c6A8OV

本文系梅斯医学（MedSci）原创编译整理，转载需授权！

版权声明：
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料，版权均属于梅斯医学所有。非经授权，任何媒体、网站或个人不得转载，授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章，或“梅斯号”自媒体发布的文章，仅系出于传递更多信息之目的，本站仅负责审核内容合规，其内容不代表本站立场，本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系，我们将立即进行删除处理。
在此留言
评论区 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1678139, encodeId=dbe916e8139a2, content=<a href='/topic/show?id=7df63110d5' target=_blank style='color:#2F92EE;'>#A型血#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3110, encryptionId=7df63110d5, topicName=A型血)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Tue Sep 17 17:30:00 CST 2019, time=2019-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1264130, encodeId=6ce5126413064, content=<a href='/topic/show?id=ffb03111a1' target=_blank style='color:#2F92EE;'>#A型血友病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3111, encryptionId=ffb03111a1, topicName=A型血友病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32d177, createdName=changfy, createdTime=Fri Nov 30 12:30:00 CST 2018, time=2018-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1318481, encodeId=280b1318481e8, content=<a href='/topic/show?id=9a535625968' target=_blank style='color:#2F92EE;'>#拜耳#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56259, encryptionId=9a535625968, topicName=拜耳)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=11b4465, createdName=ying_wu, createdTime=Fri Nov 30 12:30:00 CST 2018, time=2018-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589995, encodeId=954d158999533, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Fri Nov 30 12:30:00 CST 2018, time=2018-11-30, status=1, ipAttribution=)]
    2019-09-17 仁者大医

    #A型血#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1678139, encodeId=dbe916e8139a2, content=<a href='/topic/show?id=7df63110d5' target=_blank style='color:#2F92EE;'>#A型血#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3110, encryptionId=7df63110d5, topicName=A型血)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Tue Sep 17 17:30:00 CST 2019, time=2019-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1264130, encodeId=6ce5126413064, content=<a href='/topic/show?id=ffb03111a1' target=_blank style='color:#2F92EE;'>#A型血友病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3111, encryptionId=ffb03111a1, topicName=A型血友病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32d177, createdName=changfy, createdTime=Fri Nov 30 12:30:00 CST 2018, time=2018-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1318481, encodeId=280b1318481e8, content=<a href='/topic/show?id=9a535625968' target=_blank style='color:#2F92EE;'>#拜耳#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56259, encryptionId=9a535625968, topicName=拜耳)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=11b4465, createdName=ying_wu, createdTime=Fri Nov 30 12:30:00 CST 2018, time=2018-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589995, encodeId=954d158999533, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Fri Nov 30 12:30:00 CST 2018, time=2018-11-30, status=1, ipAttribution=)]
    2018-11-30 changfy

    #A型血友病#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1678139, encodeId=dbe916e8139a2, content=<a href='/topic/show?id=7df63110d5' target=_blank style='color:#2F92EE;'>#A型血#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3110, encryptionId=7df63110d5, topicName=A型血)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Tue Sep 17 17:30:00 CST 2019, time=2019-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1264130, encodeId=6ce5126413064, content=<a href='/topic/show?id=ffb03111a1' target=_blank style='color:#2F92EE;'>#A型血友病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3111, encryptionId=ffb03111a1, topicName=A型血友病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32d177, createdName=changfy, createdTime=Fri Nov 30 12:30:00 CST 2018, time=2018-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1318481, encodeId=280b1318481e8, content=<a href='/topic/show?id=9a535625968' target=_blank style='color:#2F92EE;'>#拜耳#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56259, encryptionId=9a535625968, topicName=拜耳)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=11b4465, createdName=ying_wu, createdTime=Fri Nov 30 12:30:00 CST 2018, time=2018-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589995, encodeId=954d158999533, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Fri Nov 30 12:30:00 CST 2018, time=2018-11-30, status=1, ipAttribution=)]
    2018-11-30 ying_wu

    #拜耳#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1678139, encodeId=dbe916e8139a2, content=<a href='/topic/show?id=7df63110d5' target=_blank style='color:#2F92EE;'>#A型血#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3110, encryptionId=7df63110d5, topicName=A型血)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Tue Sep 17 17:30:00 CST 2019, time=2019-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1264130, encodeId=6ce5126413064, content=<a href='/topic/show?id=ffb03111a1' target=_blank style='color:#2F92EE;'>#A型血友病#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3111, encryptionId=ffb03111a1, topicName=A型血友病)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32d177, createdName=changfy, createdTime=Fri Nov 30 12:30:00 CST 2018, time=2018-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1318481, encodeId=280b1318481e8, content=<a href='/topic/show?id=9a535625968' target=_blank style='color:#2F92EE;'>#拜耳#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56259, encryptionId=9a535625968, topicName=拜耳)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=11b4465, createdName=ying_wu, createdTime=Fri Nov 30 12:30:00 CST 2018, time=2018-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1589995, encodeId=954d158999533, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Fri Nov 30 12:30:00 CST 2018, time=2018-11-30, status=1, ipAttribution=)]
    2018-11-30 chenwq14

    #欧盟批准#

    0

相关资讯

Novo Nordisk在美国推出A型血友病新药Novoeight

丹麦制药巨头诺和诺德（Novo Nordisk）近日宣布，在美国推出A型血有病新药Novoeight（turoctocog alpha），该药是一种重组凝血因子VIII产品，于2013年10月获FDA批准。 NovoEight是turoctocog alpha的商品名，该药是诺和诺德第三代重组凝血因子VIII产品，利用了最新的基因重组及蛋白纯化技术。 与市面其他重组因子VIII产品相比

NEJM：emicizumab可降低体内出现抑制剂的A型血友病患者87%出血事件的发生率！

近日，来自洛杉矶儿童医院的研究人员发现，体内出现抑制剂的A型血友病患者使用一种称之为emicizumab的药物治疗，可降低87%出血事件的发生率。这项多中心III期临床研究的结果称为HAVEN 1，将在国际血栓与止血学会上展示，并将发表于NEJM。A型血友病患者血液不能正常凝固，导致不受控和频繁的持续或自发性出血，通常需要每周3次静脉注射凝血因子加以预防治疗。然而，反复使用凝血因子会导致抗体的产生

拜尔A型血友病药物Jivi获得FDA批准

拜耳公司宣布，FDA批准了其开发的Jivi（重组PEG长效化人抗血友病因子）用于常规预防性治疗先前接受过治疗的成人和12岁以上青少年的A型血友病患者。同时FDA还批准Jivi用于按需治疗血友病患者的出血围手术期处理。