心血管

订阅

MedSci主页 / 所有栏目 / 心血管

FDA评估alirocumab神经认知副作用

2014-03-26 伊文 中国医学论坛报手机报

FDAAlirocumab神经认知
关注

美国食品与药物管理局(FDA)日前要求研发降脂药物alirocumab的合作伙伴——赛诺菲和再生元(Regeneron)制药公司监测应用alirocumab患者可能的神经认知不良事件。两家公司均表示，他们并不知悉应用alirocumab与不良神经认知预后有关。alirocumab为针对前蛋白转化酶枯草溶菌素9(proprotein convertase subtilisin/kexin type

美国食品与药物管理局(FDA)日前要求研发降脂药物alirocumab的合作伙伴——赛诺菲和再生元(Regeneron)制药公司监测应用alirocumab患者可能的神经认知不良事件。

两家公司均表示，他们并不知悉应用alirocumab与不良神经认知预后有关。alirocumab为针对前蛋白转化酶枯草溶菌素9(proprotein convertase subtilisin/kexin type 9,PCSK9)的人单克隆抗体，此类单克隆抗体目前是研究热门，数个制药公司正在研发产品，如辉瑞的bococizumab和安进的evolocumab正处于研发的不同阶段。




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 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1976870, encodeId=f40b19e6870b8, content=<a href='/topic/show?id=b9f11560065' target=_blank style='color:#2F92EE;'>#ROC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15600, encryptionId=b9f11560065, topicName=ROC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d590125, createdName=linlin2312, createdTime=Fri Sep 26 12:47:00 CST 2014, time=2014-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911641, encodeId=83821911641b0, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Wed Jun 25 05:47:00 CST 2014, time=2014-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1824185, encodeId=91f9182418549, content=<a href='/topic/show?id=56a932e7800' target=_blank style='color:#2F92EE;'>#副作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32778, encryptionId=56a932e7800, topicName=副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Tue Jan 27 10:47:00 CST 2015, time=2015-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378599, encodeId=459113e85998e, content=<a href='/topic/show?id=e7f523050b' target=_blank style='color:#2F92EE;'>#Alirocumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2305, encryptionId=e7f523050b, topicName=Alirocumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Fri Mar 28 01:47:00 CST 2014, time=2014-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1603508, encodeId=fc491603508ed, content=<a href='/topic/show?id=ef43e455710' target=_blank style='color:#2F92EE;'>#神经认知#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74557, encryptionId=ef43e455710, topicName=神经认知)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2e6519038657, createdName=szhvet, createdTime=Fri Mar 28 01:47:00 CST 2014, time=2014-03-28, status=1, ipAttribution=)]
    2014-09-26 linlin2312

    #ROC#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1976870, encodeId=f40b19e6870b8, content=<a href='/topic/show?id=b9f11560065' target=_blank style='color:#2F92EE;'>#ROC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15600, encryptionId=b9f11560065, topicName=ROC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d590125, createdName=linlin2312, createdTime=Fri Sep 26 12:47:00 CST 2014, time=2014-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911641, encodeId=83821911641b0, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Wed Jun 25 05:47:00 CST 2014, time=2014-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1824185, encodeId=91f9182418549, content=<a href='/topic/show?id=56a932e7800' target=_blank style='color:#2F92EE;'>#副作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32778, encryptionId=56a932e7800, topicName=副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Tue Jan 27 10:47:00 CST 2015, time=2015-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378599, encodeId=459113e85998e, content=<a href='/topic/show?id=e7f523050b' target=_blank style='color:#2F92EE;'>#Alirocumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2305, encryptionId=e7f523050b, topicName=Alirocumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Fri Mar 28 01:47:00 CST 2014, time=2014-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1603508, encodeId=fc491603508ed, content=<a href='/topic/show?id=ef43e455710' target=_blank style='color:#2F92EE;'>#神经认知#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74557, encryptionId=ef43e455710, topicName=神经认知)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2e6519038657, createdName=szhvet, createdTime=Fri Mar 28 01:47:00 CST 2014, time=2014-03-28, status=1, ipAttribution=)]
    2014-06-25 snf701207

    #mAb#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1976870, encodeId=f40b19e6870b8, content=<a href='/topic/show?id=b9f11560065' target=_blank style='color:#2F92EE;'>#ROC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15600, encryptionId=b9f11560065, topicName=ROC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d590125, createdName=linlin2312, createdTime=Fri Sep 26 12:47:00 CST 2014, time=2014-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911641, encodeId=83821911641b0, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Wed Jun 25 05:47:00 CST 2014, time=2014-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1824185, encodeId=91f9182418549, content=<a href='/topic/show?id=56a932e7800' target=_blank style='color:#2F92EE;'>#副作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32778, encryptionId=56a932e7800, topicName=副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Tue Jan 27 10:47:00 CST 2015, time=2015-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378599, encodeId=459113e85998e, content=<a href='/topic/show?id=e7f523050b' target=_blank style='color:#2F92EE;'>#Alirocumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2305, encryptionId=e7f523050b, topicName=Alirocumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Fri Mar 28 01:47:00 CST 2014, time=2014-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1603508, encodeId=fc491603508ed, content=<a href='/topic/show?id=ef43e455710' target=_blank style='color:#2F92EE;'>#神经认知#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74557, encryptionId=ef43e455710, topicName=神经认知)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2e6519038657, createdName=szhvet, createdTime=Fri Mar 28 01:47:00 CST 2014, time=2014-03-28, status=1, ipAttribution=)]
    2015-01-27 showtest

    #副作用#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1976870, encodeId=f40b19e6870b8, content=<a href='/topic/show?id=b9f11560065' target=_blank style='color:#2F92EE;'>#ROC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15600, encryptionId=b9f11560065, topicName=ROC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d590125, createdName=linlin2312, createdTime=Fri Sep 26 12:47:00 CST 2014, time=2014-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911641, encodeId=83821911641b0, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Wed Jun 25 05:47:00 CST 2014, time=2014-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1824185, encodeId=91f9182418549, content=<a href='/topic/show?id=56a932e7800' target=_blank style='color:#2F92EE;'>#副作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32778, encryptionId=56a932e7800, topicName=副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Tue Jan 27 10:47:00 CST 2015, time=2015-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378599, encodeId=459113e85998e, content=<a href='/topic/show?id=e7f523050b' target=_blank style='color:#2F92EE;'>#Alirocumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2305, encryptionId=e7f523050b, topicName=Alirocumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Fri Mar 28 01:47:00 CST 2014, time=2014-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1603508, encodeId=fc491603508ed, content=<a href='/topic/show?id=ef43e455710' target=_blank style='color:#2F92EE;'>#神经认知#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74557, encryptionId=ef43e455710, topicName=神经认知)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2e6519038657, createdName=szhvet, createdTime=Fri Mar 28 01:47:00 CST 2014, time=2014-03-28, status=1, ipAttribution=)]
    2014-03-28 30397604

    #Alirocumab#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1976870, encodeId=f40b19e6870b8, content=<a href='/topic/show?id=b9f11560065' target=_blank style='color:#2F92EE;'>#ROC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15600, encryptionId=b9f11560065, topicName=ROC)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d590125, createdName=linlin2312, createdTime=Fri Sep 26 12:47:00 CST 2014, time=2014-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1911641, encodeId=83821911641b0, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Wed Jun 25 05:47:00 CST 2014, time=2014-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1824185, encodeId=91f9182418549, content=<a href='/topic/show?id=56a932e7800' target=_blank style='color:#2F92EE;'>#副作用#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32778, encryptionId=56a932e7800, topicName=副作用)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Tue Jan 27 10:47:00 CST 2015, time=2015-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378599, encodeId=459113e85998e, content=<a href='/topic/show?id=e7f523050b' target=_blank style='color:#2F92EE;'>#Alirocumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2305, encryptionId=e7f523050b, topicName=Alirocumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Fri Mar 28 01:47:00 CST 2014, time=2014-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1603508, encodeId=fc491603508ed, content=<a href='/topic/show?id=ef43e455710' target=_blank style='color:#2F92EE;'>#神经认知#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=74557, encryptionId=ef43e455710, topicName=神经认知)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2e6519038657, createdName=szhvet, createdTime=Fri Mar 28 01:47:00 CST 2014, time=2014-03-28, status=1, ipAttribution=)]
    2014-03-28 szhvet

    #神经认知#

    0

相关资讯

FDA授予Edison制药EPI-743快速通道地位

Edison制药3月18日宣布，FDA已授予EPI-743用于治疗弗里德赖希共济失调（Friedreich's Ataxia）的快速通道地位。此前，FDA已授予EPI-743治疗弗里德赖希共济失调的孤儿药地位。 目前，该公司正开发EPI-743用于儿童和成人线粒体疾病，包括弗里德赖希共济失调。在最近完成的一项I期和II期临床试验中，EPI-743已被证明具有良好的安全性和耐受性。此外，该公司正在

NEJM：2013获FDA批准的新分子实体

FDA药物评价与研究中心每年都会批准多种不同的药物和诊断产品。这其中有些是新分子实体(NMEs)，它们当中含有一种之前未批准过的活性成分。下面对2013年批准的27个NMEs进行了描述。 获批药物的专业类别 血液/肿瘤(8)；内分泌(3)；诊断试剂(3)；胃肠病(2)；传染疾病(2)；肺/急救护理(2)；心脏病(2)；产科/妇产科(2)；神经内科/神经外科(2)；精神病 (1)。

GSK实验性MAGE-A3免疫疗法III期肺癌研究失败

葛兰素史克（GSK）3月20日公布了实验性MAGE-A3癌症免疫疗法III期MAGRIT研究的数据。该项研究在MAGE-A3阳性非小细胞肺癌（NSCLC）患者中开展，数据表明，与安慰剂相比，MAGE-A3未能显著延长整个MAGE-A3阳性群体（首个共同主要终点）和未接受化疗的MAGE-A3阳性患者群体（第二个共同主要终点）无病生存期（DFS），未能达到研究的首个和第二个共同主要终点。 MAGRI

强生提前终止精神分裂症III期研究

强生（JNJ）3月20日宣布，遵循独立数据监测委员会（IDMC）基于积极疗效数据所做出的建议，该公司已提前终止了有关精神分裂症药物—帕利哌酮棕榈酸酯3个月配方（paliperidone palmitate 3-month formulation）的一项III期研究，这是一种实验性药物，用于精神分裂症成人患者的治疗。 该国际性、随机、多中心、双盲III期临床试验，评估了帕利哌酮棕榈酸酯3个月配方相

诺华在欧洲推出Lucentis预充注射剂

诺华（Novartis）3月20日宣布，在德国推出诺适得（Lucentis，通用名：雷珠单抗，ranibizumab）预充注射剂，该产品将于2014年在欧洲其他市场上市。预充式注射器配方，专门设计用于眼内注射，以加强患者的安全和临床医生的便利。 Lucentis预充式注射剂诸多优势，如可提供更高的剂量准确性和更方便的治疗过程，同时，不可缩回式柱塞可降低非无菌条件下不良事件的风险。这些特性有望减少

安斯泰来和Medivation向FDA提交前列腺癌药物Xtandi sNDA

安斯泰来（Astellas）和Medivation公司3月18日联合宣布，已向FDA提交了前列腺癌药物Xtandi（enzalutamide）补充新药申请（sNDA），寻求批准Xtandi用于未接受过化疗的转移性去势性前列腺癌（mCRPC）男性患者的治疗。目前，Xtandi已获批用于既往接受过多西紫杉醇化疗的mCRPC患者的治疗。 该药sNDA的提交，是基于III期PREVAIL研究的数据。该项