Aimmune的Palforzia成为美国批准的**种花生过敏治疗药物

2020-02-01 不详 MedSci原创

美国食品药品监督管理局(FDA)批准了Aimmune Therapeutics提交的Palforzia(花生过敏药,又称AR101)的申请之后,该公司股价上涨了15%。决定是在FDA咨询小组于去年9月以7 票比2 票通过的,用于治疗因意外接触花生而发生的过敏反应。

美国食品药品监督管理局(FDA)批准了Aimmune Therapeutics提交的Palforzia(花生过敏药,又称AR101)的申请之后,该公司股价上涨了15%。决定是在FDA咨询小组于去年9月以7 票比2 票通过的,用于治疗因意外接触花生而发生的过敏反应。

FDA的生物制品评估和研究中心主任Peter Marks指出:"即使严格避免,但还是会意外地接触花生引起过敏。Palforzia提供了FDA批准的治疗选择,以帮助降低花生过敏儿童中的过敏风险。"

Aimmune公司已经将Palforzia的定价定为每月890美元,它说希望医生们可以在"几周之内"开始使用该药物。

FDA的批准是基于关键的III期PALISADE试验的数据支持,该试验证明了对年龄在4至55岁花生过敏患者的意向治疗人群中的有效性,同时还基于晚期RAMSES研究的数据。此外,该文件还包括ARC001和ARC002 II期试验的结果以及正在进行的研究ARC004,ARC008和ARC011的数据。

欧洲监管机构目前正在审查这种治疗方法,以减少4至17岁儿童和青少年接触花生后出现过敏反应的频率和严重程度。

原始出处:


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    2020-09-05 xiongliangxl
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    2020-03-25 Homburg
  5. [GetPortalCommentsPageByObjectIdResponse(id=1941190, encodeId=6534194119000, content=<a href='/topic/show?id=3a862292cd' target=_blank style='color:#2F92EE;'>#ALF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2292, encryptionId=3a862292cd, topicName=ALF)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=84fb152, createdName=xiongliangxl, createdTime=Sat Sep 05 16:23:00 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2055048, encodeId=15f62055048a3, content=<a href='/topic/show?id=fa0ee98149c' target=_blank style='color:#2F92EE;'>#美国批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79814, encryptionId=fa0ee98149c, topicName=美国批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d47b2500175, createdName=12498cf9m35(暂无昵称), createdTime=Sun Mar 15 02:23:00 CST 2020, time=2020-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1921778, encodeId=63f91921e7873, content=<a href='/topic/show?id=4f0a6469837' target=_blank style='color:#2F92EE;'>#治疗药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64698, encryptionId=4f0a6469837, topicName=治疗药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9d3459, createdName=周虎, createdTime=Sat Mar 28 17:23:00 CST 2020, time=2020-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1933546, encodeId=71be1933546bc, content=<a href='/topic/show?id=53082180ed' target=_blank style='color:#2F92EE;'>#Aimmune#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2180, encryptionId=53082180ed, topicName=Aimmune)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e87d405, createdName=Homburg, createdTime=Wed Mar 25 15:23:00 CST 2020, time=2020-03-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1454788, encodeId=36021454e881a, content=<a href='/topic/show?id=b2dc1369347' target=_blank style='color:#2F92EE;'>#Palforzia#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13693, encryptionId=b2dc1369347, topicName=Palforzia)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8d175597431, createdName=whlxd, createdTime=Mon Feb 03 07:23:00 CST 2020, time=2020-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507093, encodeId=b27f150e0930e, content=<a href='/topic/show?id=43b7869368a' target=_blank style='color:#2F92EE;'>#花生过敏#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86936, encryptionId=43b7869368a, topicName=花生过敏)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Mon Feb 03 07:23:00 CST 2020, time=2020-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1519413, encodeId=f3171519413fa, content=<a href='/topic/show?id=e0e49e6858' target=_blank style='color:#2F92EE;'>#immune#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9768, encryptionId=e0e49e6858, topicName=immune)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Mon Feb 03 07:23:00 CST 2020, time=2020-02-03, status=1, ipAttribution=)]
    2020-02-03 whlxd
  6. [GetPortalCommentsPageByObjectIdResponse(id=1941190, encodeId=6534194119000, content=<a href='/topic/show?id=3a862292cd' target=_blank style='color:#2F92EE;'>#ALF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2292, encryptionId=3a862292cd, topicName=ALF)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=84fb152, createdName=xiongliangxl, createdTime=Sat Sep 05 16:23:00 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2055048, encodeId=15f62055048a3, content=<a href='/topic/show?id=fa0ee98149c' target=_blank style='color:#2F92EE;'>#美国批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79814, encryptionId=fa0ee98149c, topicName=美国批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d47b2500175, createdName=12498cf9m35(暂无昵称), createdTime=Sun Mar 15 02:23:00 CST 2020, time=2020-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1921778, encodeId=63f91921e7873, content=<a href='/topic/show?id=4f0a6469837' target=_blank style='color:#2F92EE;'>#治疗药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64698, encryptionId=4f0a6469837, topicName=治疗药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9d3459, createdName=周虎, createdTime=Sat Mar 28 17:23:00 CST 2020, time=2020-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1933546, encodeId=71be1933546bc, content=<a href='/topic/show?id=53082180ed' target=_blank style='color:#2F92EE;'>#Aimmune#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2180, encryptionId=53082180ed, topicName=Aimmune)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e87d405, createdName=Homburg, createdTime=Wed Mar 25 15:23:00 CST 2020, time=2020-03-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1454788, encodeId=36021454e881a, content=<a href='/topic/show?id=b2dc1369347' target=_blank style='color:#2F92EE;'>#Palforzia#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13693, encryptionId=b2dc1369347, topicName=Palforzia)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8d175597431, createdName=whlxd, createdTime=Mon Feb 03 07:23:00 CST 2020, time=2020-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507093, encodeId=b27f150e0930e, content=<a href='/topic/show?id=43b7869368a' target=_blank style='color:#2F92EE;'>#花生过敏#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86936, encryptionId=43b7869368a, topicName=花生过敏)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Mon Feb 03 07:23:00 CST 2020, time=2020-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1519413, encodeId=f3171519413fa, content=<a href='/topic/show?id=e0e49e6858' target=_blank style='color:#2F92EE;'>#immune#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9768, encryptionId=e0e49e6858, topicName=immune)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Mon Feb 03 07:23:00 CST 2020, time=2020-02-03, status=1, ipAttribution=)]
  7. [GetPortalCommentsPageByObjectIdResponse(id=1941190, encodeId=6534194119000, content=<a href='/topic/show?id=3a862292cd' target=_blank style='color:#2F92EE;'>#ALF#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2292, encryptionId=3a862292cd, topicName=ALF)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=84fb152, createdName=xiongliangxl, createdTime=Sat Sep 05 16:23:00 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2055048, encodeId=15f62055048a3, content=<a href='/topic/show?id=fa0ee98149c' target=_blank style='color:#2F92EE;'>#美国批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79814, encryptionId=fa0ee98149c, topicName=美国批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d47b2500175, createdName=12498cf9m35(暂无昵称), createdTime=Sun Mar 15 02:23:00 CST 2020, time=2020-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1921778, encodeId=63f91921e7873, content=<a href='/topic/show?id=4f0a6469837' target=_blank style='color:#2F92EE;'>#治疗药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64698, encryptionId=4f0a6469837, topicName=治疗药物)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c9d3459, createdName=周虎, createdTime=Sat Mar 28 17:23:00 CST 2020, time=2020-03-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1933546, encodeId=71be1933546bc, content=<a href='/topic/show?id=53082180ed' target=_blank style='color:#2F92EE;'>#Aimmune#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2180, encryptionId=53082180ed, topicName=Aimmune)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e87d405, createdName=Homburg, createdTime=Wed Mar 25 15:23:00 CST 2020, time=2020-03-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1454788, encodeId=36021454e881a, content=<a href='/topic/show?id=b2dc1369347' target=_blank style='color:#2F92EE;'>#Palforzia#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13693, encryptionId=b2dc1369347, topicName=Palforzia)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8d175597431, createdName=whlxd, createdTime=Mon Feb 03 07:23:00 CST 2020, time=2020-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1507093, encodeId=b27f150e0930e, content=<a href='/topic/show?id=43b7869368a' target=_blank style='color:#2F92EE;'>#花生过敏#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86936, encryptionId=43b7869368a, topicName=花生过敏)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Mon Feb 03 07:23:00 CST 2020, time=2020-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1519413, encodeId=f3171519413fa, content=<a href='/topic/show?id=e0e49e6858' target=_blank style='color:#2F92EE;'>#immune#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9768, encryptionId=e0e49e6858, topicName=immune)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Mon Feb 03 07:23:00 CST 2020, time=2020-02-03, status=1, ipAttribution=)]
    2020-02-03 quxin068