XENLETA(lefamulin)治疗社区获得性肺炎(CAP):欧盟CHMP持积极意见

2020-06-01 Allan MedSci原创

社区获得性肺炎(community-acquired pneumonia, CAP)是全球发病和死亡的主要原因。

社区获得性肺炎(community-acquired pneumonia, CAP)是全球发病和死亡的主要原因。CAP患者的临床表现不一,可为发热和咳痰为特征的轻症肺炎,也可为呼吸窘迫和脓毒症为特征的重症肺炎。由于CAP的临床表现广泛,所以几乎所有呼吸道疾病的鉴别诊断均包括CAP。制药公司Nabriva今日宣布,欧洲药品管理局(EMA)的人用药品委员会(CHMP)通过了一项积极意见,建议批准XENLETA(lefamulin)治疗不适合使用CAP初始治疗抗菌剂或治疗失败的社区获得性肺炎(CAP)成人患者。预计CHMP将在2020年下半年作出监管决定。

Nabriva首席医学官Jennifer Schranz博士表示:“XENLETA具有新颖的作用机制,可为成年CAP患者提供急需的短疗程治疗。我们期待着欧盟委员会的决定”。

两项III期临床试验均确定XENLETA在治疗成人CAP时不逊于莫西沙星。在这些试验中,患者对lefamulin的耐受性良好,最常见的不良反应是给药部位反应、腹泻、恶心、呕吐、肝酶升高、头痛、低血钾和失眠。

 

原始出处:

https://www.firstwordpharma.com/node/1728622?tsid=4

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    2021-02-01 smlt2008
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    2020-06-03 医生2394
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