FDA批准新型胆固醇药物(PCSK9抑制剂)

2015-07-27 MedSci MedSci原创

美国FDA近日批准了新型降胆固醇药物。赛诺菲公司的Praulent (alirocumab)获得了FDA的批准,此外安进公司的Repatha(evolocumab)将在8月27日得到FDA的最终决议。这两种注射用药物都是PCSK9抑制剂,而且FDA为这两种药物开了绿灯。这两种药物都是用于降低低密度脂蛋白(通常被称作坏的LDL胆固醇)。通过抑制PCSK9,调节机体的胆固醇水平。现在用于治疗高胆固醇的

美国FDA近日批准了新型降胆固醇药物。赛诺菲公司的Praulent (alirocumab)获得了FDA的批准,此外安进公司的Repatha(evolocumab)将在8月27日得到FDA的最终决议。这两种注射用药物都是PCSK9抑制剂,而且FDA为这两种药物开了绿灯。


这两种药物都是用于降低低密度脂蛋白(通常被称作坏的LDL胆固醇)。通过抑制PCSK9,调节机体的胆固醇水平。现在用于治疗高胆固醇的药物主要是他汀类药物。

他汀类药物与PCSK9抑制剂的作用机理不同。他汀类药物可以组织肝脏的LDL胆固醇的产生。高胆固醇会导致动脉处形成斑块,这直接导致了心脏病、堵塞和卒中。临床试验表明Praulent无论是单独使用还是联用他汀类药物,可以降低46-64%的胆固醇。每两周或者四周注射一次,而且完全可以在家里进行注射给药。FDA同时也说明了这种药物对于那些最难治疗的病人是一种选择。

美国心脏协会(AHA)在2013年的时候修订了其科学指南。AHA不再强调具体的LDL靶点的背景,推荐所用处于风险中的患者使用他汀类药物。现在由于有可能出现LDL的超低水平,考虑到PCSK9抑制剂的研发,所以仍不清楚是否会很快再次改写指南。医药数据分析公司GlobalData预测这两种药物上市后到2023年在美国以及欧洲、日本和中国的销售额将达到167亿美元。但是,这种药物对于PCSK9突变的人群并不能起作用。这些人LDL水平较低,不易患心脏疾病。

原始出处:

FDA approves new cholesterol drug.blog.heart.org.July 24,2015

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    2015-11-20 bugit
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    2016-06-17 FukaiBao
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    2016-03-15 Tamikia
  5. [GetPortalCommentsPageByObjectIdResponse(id=1786845, encodeId=f5ba1e8684584, content=<a href='/topic/show?id=4c5b138824d' target=_blank style='color:#2F92EE;'>#PCSK9抑制#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13882, encryptionId=4c5b138824d, topicName=PCSK9抑制)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1072181, createdName=wjywjy, createdTime=Sun Aug 16 21:00:00 CST 2015, time=2015-08-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839381, encodeId=3675183938118, 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=0, 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 Nov 20 18:00:00 CST 2015, time=2015-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1777235, encodeId=8ce91e7723595, content=<a href='/topic/show?id=678d5348a6' target=_blank style='color:#2F92EE;'>#Csk#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5348, encryptionId=678d5348a6, topicName=Csk)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=979839152460, createdName=FukaiBao, createdTime=Fri Jun 17 17:00:00 CST 2016, time=2016-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1685575, encodeId=8c3316855e5e2, content=<a href='/topic/show?id=a340138e48a' target=_blank style='color:#2F92EE;'>#PCS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13874, encryptionId=a340138e48a, topicName=PCS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=173d28230918, createdName=Tamikia, createdTime=Tue Mar 15 04:00:00 CST 2016, time=2016-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1851260, encodeId=7af51851260c2, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Mon Nov 16 14:00:00 CST 2015, time=2015-11-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=35117, encodeId=74083511e21, content=期待有更多研究, beContent=null, objectType=article, channel=null, level=null, likeNumber=133, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 23:13:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=33800, encodeId=bc1233800e2, content=前蛋白转化酶枯草溶菌素9, beContent=null, objectType=article, channel=null, level=null, likeNumber=145, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=acdd1632351, createdName=bearing, createdTime=Wed Jul 29 17:17:00 CST 2015, time=2015-07-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=33631, encodeId=61b53363166, content=我想知道中文名叫什么, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ed101627734, createdName=Messichen1992, createdTime=Tue Jul 28 08:47:00 CST 2015, time=2015-07-28, status=1, ipAttribution=)]
    2015-11-16 jklm09
  6. [GetPortalCommentsPageByObjectIdResponse(id=1786845, encodeId=f5ba1e8684584, content=<a href='/topic/show?id=4c5b138824d' target=_blank style='color:#2F92EE;'>#PCSK9抑制#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13882, encryptionId=4c5b138824d, topicName=PCSK9抑制)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1072181, createdName=wjywjy, createdTime=Sun Aug 16 21:00:00 CST 2015, time=2015-08-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839381, encodeId=3675183938118, 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=0, 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 Nov 20 18:00:00 CST 2015, time=2015-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1777235, encodeId=8ce91e7723595, content=<a href='/topic/show?id=678d5348a6' target=_blank style='color:#2F92EE;'>#Csk#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5348, encryptionId=678d5348a6, topicName=Csk)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=979839152460, createdName=FukaiBao, createdTime=Fri Jun 17 17:00:00 CST 2016, time=2016-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1685575, encodeId=8c3316855e5e2, content=<a href='/topic/show?id=a340138e48a' target=_blank style='color:#2F92EE;'>#PCS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13874, encryptionId=a340138e48a, topicName=PCS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=173d28230918, createdName=Tamikia, createdTime=Tue Mar 15 04:00:00 CST 2016, time=2016-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1851260, encodeId=7af51851260c2, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Mon Nov 16 14:00:00 CST 2015, time=2015-11-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=35117, encodeId=74083511e21, content=期待有更多研究, beContent=null, objectType=article, channel=null, level=null, likeNumber=133, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=332823945, createdName=hlycom3356, createdTime=Thu Aug 06 23:13:00 CST 2015, time=2015-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=33800, encodeId=bc1233800e2, content=前蛋白转化酶枯草溶菌素9, beContent=null, objectType=article, channel=null, level=null, likeNumber=145, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=acdd1632351, createdName=bearing, createdTime=Wed Jul 29 17:17:00 CST 2015, time=2015-07-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=33631, encodeId=61b53363166, content=我想知道中文名叫什么, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ed101627734, createdName=Messichen1992, createdTime=Tue Jul 28 08:47:00 CST 2015, time=2015-07-28, status=1, ipAttribution=)]
    2015-08-06 hlycom3356

    期待有更多研究

    0

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    2015-07-29 bearing

    前蛋白转化酶枯草溶菌素9

    0

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    2015-07-28 Messichen1992

    我想知道中文名叫什么

    0

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