Galapagos制药旗下骨关节炎药物GLPG1972 / S201086获得FDA快速通道认定

2018-11-28 MedSci MedSci原创

Galapagos制药正在开发的GLPG1972 / S201086药物有可能成为一流的骨关节炎药物(DMOAD)。2018年6月,Galapagos和Servier宣布开始为期52周的全球ROCCELLA II期试验,用于评价GLPG1972 / S201086治疗膝关节骨性关节炎的有效性和安全性。Galapagos制药首席营销官Walid Abi-Saab博士说:“FDA的快速通道认定是对GL

骨关节炎(OsteoarthritisOA)是一种关节软骨或关节下骨头损伤的关节炎,常见症状是关节疼痛或僵硬,初次发病常仅见于运动之后但发病次数会随时间增加,其他症状包含关节肿胀、关节活动度降低,若累及背部则可能导致四肢无力或麻木。

Galapagos制药正在开发的GLPG1972 / S201086药物有可能成为一流的骨关节炎药物(DMOAD)。20186月,GalapagosServier宣布开始为期52周的全球ROCCELLA II期试验,用于评价GLPG1972 / S201086治疗膝关节骨性关节炎的有效性和安全性。Galapagos制药首席营销官Walid Abi-Saab博士说:FDA的快速通道认定是对GLPG1972 / S201086作为新治疗方案的肯定美国食品和药物管理局(FDA)的快速通道计划旨在促进药物的开发和加速审查,以治疗严重或危及生命的疾病或病症。获得此认定的企业有资格与FDA进行更频繁的互动,并且可能有资格对新药申请(NDA)进行优先审查和滚动审查。


原始出处:

http://www.firstwordpharma.com/node/1607476#axzz5Y7c6A8OV

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    2019-04-13 LSJ122
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    2019-01-31 lq1767
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    2019-10-11 lisa438
  6. [GetPortalCommentsPageByObjectIdResponse(id=2077062, encodeId=e7c920e70621f, content=<a href='/topic/show?id=955d226045' target=_blank style='color:#2F92EE;'>#ALA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2260, encryptionId=955d226045, topicName=ALA)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/lGEyfsKnIkkH93xUPMrUUycLh2XOfJJsphwPsVqDx8somSOepIFy9QE0MVAwDW3AS7V1epJ4tbPL9ADJLicvm8A/132, createdBy=b5132500067, createdName=ms55066533437992, createdTime=Mon Dec 24 22:29:00 CST 2018, time=2018-12-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1734671, encodeId=37011e3467175, content=<a href='/topic/show?id=2239106951c' target=_blank style='color:#2F92EE;'>#LAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10695, encryptionId=2239106951c, topicName=LAP)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=06de33803044, createdName=LSJ122, createdTime=Sat Apr 13 14:29:00 CST 2019, time=2019-04-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1793527, encodeId=aafe1e9352772, content=<a href='/topic/show?id=8f261581691' target=_blank style='color:#2F92EE;'>#S201086#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15816, encryptionId=8f261581691, topicName=S201086)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=19ad38, createdName=lq1767, createdTime=Thu Jan 31 00:29:00 CST 2019, time=2019-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1763424, encodeId=72ab1e634246d, content=<a href='/topic/show?id=45a23011907' target=_blank style='color:#2F92EE;'>#关节炎药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30119, encryptionId=45a23011907, topicName=关节炎药物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c96b37532351, createdName=ms6519009802973839, createdTime=Tue Jan 15 06:29:00 CST 2019, time=2019-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2026603, encodeId=2caa2026603b7, content=<a href='/topic/show?id=e0b110159578' target=_blank style='color:#2F92EE;'>#骨关节#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101595, encryptionId=e0b110159578, topicName=骨关节)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=373b263, createdName=lisa438, createdTime=Fri Oct 11 09:29:00 CST 2019, time=2019-10-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1265855, encodeId=5933126585539, content=<a href='/topic/show?id=57a53011364' target=_blank style='color:#2F92EE;'>#关节炎#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30113, encryptionId=57a53011364, topicName=关节炎)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f90281, createdName=lmm397, createdTime=Fri Nov 30 14:29:00 CST 2018, time=2018-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338190, encodeId=9a4b133819075, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Fri Nov 30 14:29:00 CST 2018, time=2018-11-30, status=1, ipAttribution=)]
    2018-11-30 lmm397
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