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欧洲委员会将营销许可授予Vabomere

2018-11-28 MedSci MedSci原创

Vabomere营销许可严重细菌感染
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Melinta是一家开发新型抗生素以治疗严重细菌感染的制药公司，Melinta近日宣布欧盟委员会已经批准其Vabomere（Meropenem/vaborbactam）用于治疗复杂的腹腔内（cIAI）、尿路感染（cUTI）、医院获得性肺炎、感染相关的菌血症以及好氧革兰氏阴性菌引起的感染的成人患者。Vabomere在所有欧盟（EU）成员国以及挪威、冰岛和列支敦士登均获得了营销许可。

Melinta是一家开发新型抗生素以治疗严重细菌感染的制药公司，Melinta近日宣布欧盟委员会已经批准其Vabomere（Meropenem/vaborbactam）用于治疗复杂的腹腔内（cIAI）、尿路感染（cUTI）、医院获得性肺炎、感染相关的菌血症以及好氧革兰氏阴性菌引起的感染的成人患者。Vabomere在所有欧盟（EU）成员国以及挪威、冰岛和列支敦士登均获得了营销许可。

Melinta的首席执行官兼董事John H. Johnson说：“越来越多的耐药性肠杆菌科已经对全球患者构成了重大威胁。随着欧洲委员会对Vabomere的授权，预计Vabomere能够杀灭这种危及生命的病原体”。这项批准源自于欧洲药品管理局（EMA）的人用药品委员会（CHMP）于2018年9月发布的积极意见，该意见则基于TANGO临床计划的数据。TANGO-1是一项III期、多中心、随机、双盲、双模拟研究，评估了Vabomere与哌拉西林-他唑巴坦治疗成人cUTI（包括急性肾盂肾炎）的有效性、安全性和耐受性。TANGO-2则是一项多中心、随机、开放标签的临床试验，评估了Vabomere与碳青霉烯类在有效性和安全性方面的差异。


原始出处：

http://www.firstwordpharma.com/node/1607240#axzz5Y7c6A8OV

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    2019-03-15 ms2999106592497887

    #欧洲委员会#

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    2018-11-30 zhouqu_8

    #欧洲#

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    2018-11-30 闆锋旦

    #ABO#

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