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详解2016年FDA批准的20款创新药(名称、活性成分、适应症……)

2017-02-10 佚名 生物探索

12月14日,FDA公布了2016年批准的第20个新分子药物Eucrisa,而后朋友圈被“CDER新药办公室主任John K. Jenkins博士的FDA新药审评情况”一文刷屏了。到目前为止FDA仅批准20个新分子药物,远低于去年的45个。本文详细解析了这20款创新药物的名称、活性成分、适应症……

截止至2016年12月14日,FDA下属药品审评与研究中心(CDER)共批准了20个创新药:包括13个新药上市申请(NDA)、7个生物制品上市许可申请(BLA)。

具体名单见表1(备注:绿色背景的表示“生物制品”)。

表1:FDA2016年批准的创新药物名单


数量&质量

从数量上看,今年获批的新药数较去年产生了明显的下降。2015年,FDA批准了45款新药,创下了数十年来的新高。而2016年,这一数字则是近10年来的第二低,仅高于2007年的18款新药。不过,数字背后是小分子新药锐减,生物制品则热度不减。

从质量上看,在这20款新药中,有7款为生物制品,比例占新药总数的35%,不仅超过了去年的26.7%,更是达到了数十年来的最高值。这反映出生物制剂研发领域的强劲发展势头。

治疗领域

从治疗领域来看,2016年FDA批准新药包括:

5个与肿瘤相关的药物(诊断试剂):治疗慢性淋巴细胞白血病(CLL)的Venclexta,尿路上皮癌、膀胱癌/肺癌药物Tecentriq,软组织肉瘤药物Lartruvo,用于检测罕见神经内分泌肿瘤的Netspot和用于复发性前列腺癌检查的新型影像剂Axumin;

5个抗感染药物:抗丙肝药物Zepatier,治疗6种基因型丙肝的药物Epclusa,抗炭疽热药物Anthim和抗艰难梭菌感染药物Zinplava,肝病新药Ocaliva(一种鹅脱氧胆酸衍生物);

3个神经系统药物:抗癫痫药物Briviact,帕金森精神病药物Nuplazid和多发性硬化症药物Zinbryta;

3个免疫药物:银屑病(牛皮癣)药物Taltz、哮喘药物Cinqair和轻中度湿疹药物Eucrisa。

1个代谢性疾病药物:2型糖尿病新药Adlyxin;

3个其他类型:用于成人和儿童治疗由血液干细胞移植造成的肝静脉阻塞的Defitelio,干眼症新药Xiidra,遗传性疾病杜氏肌营养不良药物Exondys。

审批类型


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    2017-09-22 bugit
  2. [GetPortalCommentsPageByObjectIdResponse(id=1839491, encodeId=434418394915b, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Fri Sep 22 21:31:00 CST 2017, time=2017-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175729, encodeId=2d1d1e57292a, content=越多越好啊!, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRkia1DP5MpwEgtXo1XhXA11xD6MWKxunAZFXKSNic0fWHUQx83oNHPlRMxxIctM83QKeCLkJpMibibiaC/0, createdBy=7e581734408, createdName=深海的鱼, createdTime=Sun Feb 12 10:44:42 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175700, encodeId=e3101e570002, content=了解一下。, beContent=null, objectType=article, channel=null, level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160616/IMG5762A3665DC7B3997.jpg, createdBy=df0a1649089, createdName=ys2323, createdTime=Sun Feb 12 08:16:27 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1285317, encodeId=49f6128531e3f, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32094, encryptionId=77903209422, topicName=创新)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512a199, createdName=lilianxiang, createdTime=Sun Feb 12 06:31:00 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336741, encodeId=a6d81336e41dd, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Sun Feb 12 06:31:00 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175663, encodeId=c3ac1e566335, content=fda是比较好的标准, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/30/dd6bade062cb598667f9f577194196c4.jpg, createdBy=422e1687020, createdName=Dr.jerry, createdTime=Sun Feb 12 00:57:23 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175512, encodeId=a78a1e5512f1, content=文章不错,拜读了, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Sat Feb 11 08:39:29 CST 2017, time=2017-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175486, encodeId=63bd1e5486a5, content=免疫系统的新药也这么多, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170206/IMG589879E392F941842.jpg, createdBy=f4d469996, createdName=wangyunyb, createdTime=Sat Feb 11 07:01:14 CST 2017, time=2017-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175416, encodeId=ad741e54161a, content=疾病模型研究会, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLBkyaelI9ia3n9SbuKmBdaY0PqCOzd0nhRUstroXmUmXZ5EBTmibtLEvCCIpyHAqxQXGfZz49ibrwjkg/0, createdBy=39781652829, createdName=雾夜芭蕾, createdTime=Fri Feb 10 19:28:37 CST 2017, time=2017-02-10, status=1, ipAttribution=)]
    2017-02-12 深海的鱼

    越多越好啊!

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1839491, encodeId=434418394915b, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Fri Sep 22 21:31:00 CST 2017, time=2017-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175729, encodeId=2d1d1e57292a, content=越多越好啊!, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRkia1DP5MpwEgtXo1XhXA11xD6MWKxunAZFXKSNic0fWHUQx83oNHPlRMxxIctM83QKeCLkJpMibibiaC/0, createdBy=7e581734408, createdName=深海的鱼, createdTime=Sun Feb 12 10:44:42 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175700, encodeId=e3101e570002, content=了解一下。, beContent=null, objectType=article, channel=null, level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160616/IMG5762A3665DC7B3997.jpg, createdBy=df0a1649089, createdName=ys2323, createdTime=Sun Feb 12 08:16:27 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1285317, encodeId=49f6128531e3f, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32094, encryptionId=77903209422, topicName=创新)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512a199, createdName=lilianxiang, createdTime=Sun Feb 12 06:31:00 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336741, encodeId=a6d81336e41dd, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Sun Feb 12 06:31:00 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175663, encodeId=c3ac1e566335, content=fda是比较好的标准, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/30/dd6bade062cb598667f9f577194196c4.jpg, createdBy=422e1687020, createdName=Dr.jerry, createdTime=Sun Feb 12 00:57:23 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175512, encodeId=a78a1e5512f1, content=文章不错,拜读了, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Sat Feb 11 08:39:29 CST 2017, time=2017-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175486, encodeId=63bd1e5486a5, content=免疫系统的新药也这么多, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170206/IMG589879E392F941842.jpg, createdBy=f4d469996, createdName=wangyunyb, createdTime=Sat Feb 11 07:01:14 CST 2017, time=2017-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175416, encodeId=ad741e54161a, content=疾病模型研究会, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLBkyaelI9ia3n9SbuKmBdaY0PqCOzd0nhRUstroXmUmXZ5EBTmibtLEvCCIpyHAqxQXGfZz49ibrwjkg/0, createdBy=39781652829, createdName=雾夜芭蕾, createdTime=Fri Feb 10 19:28:37 CST 2017, time=2017-02-10, status=1, ipAttribution=)]
    2017-02-12 ys2323

    了解一下。

    0

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  5. [GetPortalCommentsPageByObjectIdResponse(id=1839491, encodeId=434418394915b, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Fri Sep 22 21:31:00 CST 2017, time=2017-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175729, encodeId=2d1d1e57292a, content=越多越好啊!, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRkia1DP5MpwEgtXo1XhXA11xD6MWKxunAZFXKSNic0fWHUQx83oNHPlRMxxIctM83QKeCLkJpMibibiaC/0, createdBy=7e581734408, createdName=深海的鱼, createdTime=Sun Feb 12 10:44:42 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175700, encodeId=e3101e570002, content=了解一下。, beContent=null, objectType=article, channel=null, level=null, likeNumber=108, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160616/IMG5762A3665DC7B3997.jpg, createdBy=df0a1649089, createdName=ys2323, createdTime=Sun Feb 12 08:16:27 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1285317, encodeId=49f6128531e3f, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32094, encryptionId=77903209422, topicName=创新)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512a199, createdName=lilianxiang, createdTime=Sun Feb 12 06:31:00 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336741, encodeId=a6d81336e41dd, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Sun Feb 12 06:31:00 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175663, encodeId=c3ac1e566335, content=fda是比较好的标准, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2017/04/30/dd6bade062cb598667f9f577194196c4.jpg, createdBy=422e1687020, createdName=Dr.jerry, createdTime=Sun Feb 12 00:57:23 CST 2017, time=2017-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175512, encodeId=a78a1e5512f1, content=文章不错,拜读了, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Sat Feb 11 08:39:29 CST 2017, time=2017-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175486, encodeId=63bd1e5486a5, content=免疫系统的新药也这么多, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170206/IMG589879E392F941842.jpg, createdBy=f4d469996, createdName=wangyunyb, createdTime=Sat Feb 11 07:01:14 CST 2017, time=2017-02-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=175416, encodeId=ad741e54161a, content=疾病模型研究会, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLBkyaelI9ia3n9SbuKmBdaY0PqCOzd0nhRUstroXmUmXZ5EBTmibtLEvCCIpyHAqxQXGfZz49ibrwjkg/0, createdBy=39781652829, createdName=雾夜芭蕾, createdTime=Fri Feb 10 19:28:37 CST 2017, time=2017-02-10, status=1, ipAttribution=)]
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    2017-02-12 Dr.jerry

    fda是比较好的标准

    0

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    2017-02-11 1e10c84am36(暂无匿称)

    文章不错,拜读了

    0

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    2017-02-11 wangyunyb

    免疫系统的新药也这么多

    0

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    2017-02-10 雾夜芭蕾

    疾病模型研究会

    0

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