消除胃癌潜在隐患 FDA批准创新幽门螺杆菌清除疗法上市

2019-11-06 佚名 药明康德

今日,RedHill Biopharma公司宣布,美国FDA批准其创新疗法Talicia上市,用于治疗感染幽门螺杆菌的成人患者。Talicia是目前唯一一款获得FDA批准的基于利福布汀(rifabutin)的幽门螺杆菌清除疗法,旨在解决幽门螺杆菌对标准护理疗法中常用抗生素的耐药性问题。RedHill公司计划于2020年第一季度将Talicia推向美国市场。

今日,RedHill Biopharma公司宣布,美国FDA批准其创新疗法Talicia上市,用于治疗感染幽门螺杆菌的成人患者。Talicia是目前唯一一款获得FDA批准的基于利福布汀(rifabutin)的幽门螺杆菌清除疗法,旨在解决幽门螺杆菌对标准护理疗法中常用抗生素的耐药性问题。RedHill公司计划于2020年第一季度将Talicia推向美国市场。

幽门螺杆菌感染是导致癌的最危险因素之一,被归为癌的一类致癌物。它也是引起消化性溃疡,胃粘膜相关淋巴组织(MALT)淋巴瘤的主要危险因素之一。它使患者患有非贲门胃癌和MALT淋巴瘤的发生几率提高6倍。在全世界范围内,幽门螺杆菌感染影响了50%以上的成年人。据统计,2009年至2013年间,幽门螺杆菌对标准护理疗法中常用的抗生素克林霉素的耐药性增加了一倍以上。患者急需新型的幽门螺杆菌清除疗法,对抗这一耐药问题。

Talicia是一款新型的固定剂量口服胶囊,其配方包含2种抗生素:利福布汀和阿莫西林(amoxicillin),以及1种质子泵抑制剂(PPI)奥美拉唑(omeprazole)。此前,FDA已授予Talicia合格传染病产品(QIDP)资格,优先审评资格,以及快速通道资格。

Talicia的批准是基于两项3期临床研究的积极结果。其中一项验证性3期试验的结果显示,84%接受Talicia治疗的患者的幽门螺杆菌感染得到清除,而对照组中这一数据为58%,具有统计学上的显着差异。此外,在试验中未检测到对利福布汀的耐药性,利福布汀是Talicia独特配方中的关键组成部分。

“Talicia具有出色的安全性和疗效,且不受克林霉素和甲硝唑高耐药性的影响,为感染幽门螺杆菌的患者提供了一种新的治疗选择,“休斯敦贝勒医学院(Baylor College of Medicine)的David Y. Graham医学博士说:”由于耐药性的不断提高,25%-40%接受克林霉素治疗的患者的治疗效果不佳。临床研究表明,Talicia可有效清除幽门螺杆菌,在试验中未检测到对利福布汀的耐药性。“

“FDA对Talicia的批准体现了我们在研发胃肠道疾病治疗药物的奉献精神和持久承诺,”RedHill首席执行官Dror Ben-Asher先生说:“在此,我们感谢参与Talicia研究的患者,研究人员,以及RedHill团队,是他们的不懈努力和辛勤工作使这一重要里程碑变为现实。“

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1811802, encodeId=09f0181180248, content=<a href='/topic/show?id=751f8889423' target=_blank style='color:#2F92EE;'>#螺杆菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88894, encryptionId=751f8889423, topicName=螺杆菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=87b1109, createdName=kcb069, createdTime=Sat May 23 12:49:00 CST 2020, time=2020-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=883634, encodeId=09a38836340d, content=疑问,Talicia核心技术是三种药的成分配比吗, 这三种药都是常规药,不是很容易被模仿吗。, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9b195399699, createdName=sandy99, createdTime=Tue Sep 08 15:22:55 CST 2020, time=2020-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839739, encodeId=f0461839e396b, 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=24, 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=Thu Jul 23 17:49:00 CST 2020, time=2020-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1285807, encodeId=fcc7128580ed5, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, 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=Fri Nov 08 03:49:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=374857, encodeId=6fd73e4857ea, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Wed Nov 06 12:58:13 CST 2019, time=2019-11-06, status=1, ipAttribution=)]
    2020-05-23 kcb069
  2. [GetPortalCommentsPageByObjectIdResponse(id=1811802, encodeId=09f0181180248, content=<a href='/topic/show?id=751f8889423' target=_blank style='color:#2F92EE;'>#螺杆菌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88894, encryptionId=751f8889423, topicName=螺杆菌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=87b1109, createdName=kcb069, createdTime=Sat May 23 12:49:00 CST 2020, time=2020-05-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=883634, encodeId=09a38836340d, content=疑问,Talicia核心技术是三种药的成分配比吗, 这三种药都是常规药,不是很容易被模仿吗。, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9b195399699, createdName=sandy99, createdTime=Tue Sep 08 15:22:55 CST 2020, time=2020-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839739, encodeId=f0461839e396b, 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=24, 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=Thu Jul 23 17:49:00 CST 2020, time=2020-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1285807, encodeId=fcc7128580ed5, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, 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=Fri Nov 08 03:49:00 CST 2019, time=2019-11-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=374857, encodeId=6fd73e4857ea, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Wed Nov 06 12:58:13 CST 2019, time=2019-11-06, status=1, ipAttribution=)]
    2020-09-08 sandy99

    疑问,Talicia核心技术是三种药的成分配比吗, 这三种药都是常规药,不是很容易被模仿吗。

    0

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    2020-07-23 bugit
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    2019-11-06 1ddf0692m34(暂无匿称)

    学习了,谢谢分享

    0

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