Radius新型骨质疏松症药物abaloparatide III期临床获得成功,将成礼来重磅药物Forteo(特立帕肽)劲敌

2016-08-18 佚名 生物谷

美国生物制药公司Radius Health近日公布了新型骨质疏松症药物abaloparatide一项里程碑意义的III期临床研究(ACTIVE)的积极数据。该研究在2463例绝经后骨质疏松症女性患者中开展,评估了每日一次皮下注射abaloparatide降低椎体和非椎体骨折风险的疗效和安全性。数据显示,连续治疗18个月时,与安慰剂相比,每日一次皮下注射80微克abaloparatide使新发椎体骨

美国生物制药公司Radius Health近日公布了新型骨质疏松症药物abaloparatide一项里程碑意义的III期临床研究(ACTIVE)的积极数据。该研究在2463例绝经后骨质疏松症女性患者中开展,评估了每日一次皮下注射abaloparatide降低椎体和非椎体骨折风险的疗效和安全性。数据显示,连续治疗18个月时,与安慰剂相比,每日一次皮下注射80微克abaloparatide使新发椎体骨折(p<0.001)和非椎体骨折(p=0.049)发生率均实现统计学意义的显著降低。详细数据已发表于本周的美国医学协会杂志(JAMA)。

abaloparatide是一种新型合成肽,是甲状旁腺激素受体(PTH1受体)的一种选择性激活剂,由于其具有良好的成骨活性,因此被推进临床开发,用于伴有骨折高风险的绝经后女性骨质疏松症的治疗。目前,abaloparatide已完成III期临床开发,作为一种日常自我注射药物(abaloparatide-SC,皮下注射剂型),用于绝经后骨质疏松症女性患者群体。

监管方面,Radius公司已于2015年第四季度向欧盟委员会(EC)提交了abaloparatide-SC的上市申请文件,预计将在年底获批。美国方面,该公司已于2016年第一季度向FDA提交了abaloparatide-SC的新药申请(NDA),预计将在2017年3月获批。此外,该公司也正在开发透皮给药剂型的abaloparatide(abaloparatide-TD),这种透皮剂型采用了其3M专利的微透皮给药系统技术。

目前,骨质疏松症新药研发领域,美国生物技术巨头安进(Amgen)与合作伙伴UCB合作开发的另一款新型骨质疏松症药物romosozumab也非常值得期待,该药是一种单抗,通过抑制骨硬化蛋白(sclerostin)活性而促进骨形成并减少骨吸收。临床推进方面,romosozumab于今年年初成功完成治疗女性骨质疏松症的大型III期临床项目。此外,romosozumab治疗男性骨质疏松症III期研究也获得了成功,与安慰剂相比,romosozumab治疗12个月使骨质疏松症男性患者的腰椎、股骨颈、全髋关节骨密度(BMD)均实现统计学意义的显著增加。

业界对abaloparatide和romosozumab的商业前景十分看好,如果上市,这2种药物都将对礼来的药物Forteo(teriparatide,特立帕肽)形成严重威胁,后者是一款年销售额超过10亿美元的骨质疏松症重磅药物。

Radius Health是一家科研驱动的生物制药公司,专注于骨质疏松症、肿瘤学及内分泌疾病。该公司于2014年IPO,当年圣诞节前夕,abaloparatide在一项III期临床中展现惊人疗效,助推该公司股票飙升近4倍。目前该公司市值已达到23亿美元。

原始出处:

Radius osteoporosis drug bests placebo in PhIII; eyes 2017 FDA approval

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03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594453, encodeId=da78159445326, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=)]
    2016-12-22 juliusluan78
  4. [GetPortalCommentsPageByObjectIdResponse(id=1652767, encodeId=24c01652e67ec, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Wed Dec 14 11:02:00 CST 2016, time=2016-12-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1679630, encodeId=8e5316e963080, content=<a href='/topic/show?id=2214960117d' target=_blank style='color:#2F92EE;'>#重磅药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96011, encryptionId=2214960117d, topicName=重磅药物)], attachment=null, authenticateStatus=null, createdAvatar=null, 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03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594453, encodeId=da78159445326, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=)]
    2016-09-18 ylzr123

    好文,从这里学习了好多新知识,新信息。赞了!

    0

  5. 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03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594453, encodeId=da78159445326, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=)]
    2016-08-20 136****0753赵

    值得学习

    0

  6. 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03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594453, encodeId=da78159445326, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=)]
  7. 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createdBy=4bde27802965, createdName=qindq, createdTime=Fri Oct 21 07:02:00 CST 2016, time=2016-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1915918, encodeId=bedd1915918eb, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Thu Dec 22 02:02:00 CST 2016, time=2016-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=130570, encodeId=70511305e092, content=好文,从这里学习了好多新知识,新信息。赞了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548883, encodeId=40cb15488839b, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588681, encodeId=e8731588681c5, content=<a href='/topic/show?id=f31e680240e' target=_blank style='color:#2F92EE;'>#特立帕肽#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68024, encryptionId=f31e680240e, topicName=特立帕肽)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a75d17610690, createdName=yyj068, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1592339, encodeId=6619159233967, content=<a href='/topic/show?id=6dc2101853ed' target=_blank style='color:#2F92EE;'>#骨质#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101853, encryptionId=6dc2101853ed, topicName=骨质)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e1d018108513, createdName=Eleven17, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594453, encodeId=da78159445326, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=)]
    2016-08-20 xxxx1054
  8. [GetPortalCommentsPageByObjectIdResponse(id=1652767, encodeId=24c01652e67ec, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Wed Dec 14 11:02:00 CST 2016, time=2016-12-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1679630, encodeId=8e5316e963080, content=<a href='/topic/show?id=2214960117d' target=_blank style='color:#2F92EE;'>#重磅药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96011, encryptionId=2214960117d, topicName=重磅药物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4bde27802965, createdName=qindq, createdTime=Fri Oct 21 07:02:00 CST 2016, time=2016-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1915918, encodeId=bedd1915918eb, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Thu Dec 22 02:02:00 CST 2016, time=2016-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=130570, encodeId=70511305e092, content=好文,从这里学习了好多新知识,新信息。赞了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1548883, encodeId=40cb15488839b, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1588681, encodeId=e8731588681c5, content=<a href='/topic/show?id=f31e680240e' target=_blank style='color:#2F92EE;'>#特立帕肽#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68024, encryptionId=f31e680240e, topicName=特立帕肽)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a75d17610690, createdName=yyj068, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1592339, encodeId=6619159233967, content=<a href='/topic/show?id=6dc2101853ed' target=_blank style='color:#2F92EE;'>#骨质#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101853, encryptionId=6dc2101853ed, topicName=骨质)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e1d018108513, createdName=Eleven17, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594453, encodeId=da78159445326, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=)]
  9. 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encodeId=e8731588681c5, content=<a href='/topic/show?id=f31e680240e' target=_blank style='color:#2F92EE;'>#特立帕肽#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=68024, encryptionId=f31e680240e, topicName=特立帕肽)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a75d17610690, createdName=yyj068, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1592339, encodeId=6619159233967, content=<a href='/topic/show?id=6dc2101853ed' target=_blank style='color:#2F92EE;'>#骨质#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101853, encryptionId=6dc2101853ed, topicName=骨质)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e1d018108513, createdName=Eleven17, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1594453, encodeId=da78159445326, content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Sat Aug 20 03:02:00 CST 2016, time=2016-08-20, status=1, ipAttribution=)]
    2016-08-20 Eleven17
  10. 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