阿斯利康的心力衰竭药物SGLT2抑制剂Farxiga获得FDA优先审查

2020-01-06 不详 MedSci原创

阿斯利康的心力衰竭药物SGLT2抑制剂Farxiga已获得美国FDA的优先审查,预计将在2020年第二季度获得批准。

阿斯利康的心力衰竭药物SGLT2抑制剂Farxiga已获得美国FDA的优先审查,预计将在2020年第二季度获得批准。

AZ提交了Farxiga(dapagliflozin)的补充新药申请(sNDA),以降低射血分数降低(HFrEF)的成年患者(无论是否患有2型糖尿病)的心血管死亡或心力衰竭恶化的风险。

Farxiga于2019年10月在美国获批,成为首个在美国获得批准用于降低2型糖尿病和具有其他心血管风险患者因心脏衰竭住院几率的SGLT2抑制剂。

该批准基于DECLARE-TIMI 58临床试验的结果,结果表明Farxiga能够减少糖尿病患者人群因心力衰竭和心血管死亡而住院的人数。

随着该药物进入专利保护的最后几年,HFrEF的批准将为该药物带来更大的市场机会。

阿斯利康在Farxiga的HFrEF试验中将其命名为DAPA-HF,该试验在去年的欧洲心脏病学会大会上被誉为"具有里程碑意义的试验"。

该试验的数据表明,将Farxiga添加到标准疗法中后,可使心血管死亡或心力衰竭加重的症状降低26%。

阿斯利康研发执行副总裁Mene Pangalos表示:"Farxiga在2型糖尿病的治疗方面已经建立了完善的技术,这项优先审查显示出它有可能影响数百万名心力衰竭患者。"

他补充说:"如果获得批准,Farxiga将成为治疗心力衰竭患者的首个也是唯一的同类药物。"

原始出处:


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    2020-08-22 jklm09
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    2020-04-13 tulenzi
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  5. 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time=2020-01-08, status=1, ipAttribution=)]
  6. 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  7. 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href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9477, encryptionId=641d94e7eb, topicName=IgA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c23f9697922, createdName=yibei, createdTime=Wed Jan 08 13:09:00 CST 2020, time=2020-01-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1533464, encodeId=3f1f153346406, content=<a href='/topic/show?id=23be16229ce' target=_blank style='color:#2F92EE;'>#SGLT2抑制剂Farxiga#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16229, encryptionId=23be16229ce, topicName=SGLT2抑制剂Farxiga)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b7fa12453417, createdName=天堂的云, createdTime=Wed Jan 08 13:09:00 CST 2020, time=2020-01-08, status=1, ipAttribution=)]
    2020-01-08 jiekemin
  8. 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    2020-01-08 yibei
  9. 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