Cefepime/Enmetazobactam: First Approval.

IF 13 1区医学 Q1 PHARMACOLOGY & PHARMACY Drugs Pub Date : 2024-06-01 Epub Date: 2024-05-18 DOI:10.1007/s40265-024-02035-2

Susan J Keam

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Abstract

Cefepime/enmetazobactam (EXBLIFEP^®), an intravenous (IV) antibacterial fixed-dose combination of a 4th generation cephalosporin and an extended-spectrum β-lactamase (ESBL) inhibitor, is being developed by Allecra Therapeutics and ADVANZ PHARMA for the treatment of infections caused by multi-drug-resistant (MDR) Gram-negative bacteria. In February 2024, cefepime/enmetazobactam was approved in the USA for use in adults with complicated urinary tract infections (cUTI) including pyelonephritis, caused by susceptible strains of Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex. In March 2024, cefepime/enmetazobactam was approved in the EU for use in adults for the treatment of cUTI, including pyelonephritis, and hospital-acquired pneumonia, including ventilator associated pneumonia, and the treatment of patients with bacteraemia occurring in association with or suspected to be associated with any of these infections. This article summarizes the milestones in the development of cefepime/enmetazobactam leading to this first approval for the treatment of adults with infections caused by MDR Gram-negative bacteria.

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头孢吡肟/恩美唑巴坦：首次批准。

头孢吡肟/恩美唑巴坦（EXBLIFEP®）是由第四代头孢菌素和广谱β-内酰胺酶（ESBL）抑制剂组成的静脉注射（IV）抗菌固定剂量复方制剂，由 Allecra Therapeutics 和 ADVANZ PHARMA 共同开发，用于治疗由多重耐药（MDR）革兰氏阴性菌引起的感染。2024 年 2 月，头孢吡肟/恩美唑巴坦在美国获批用于治疗由易感菌株大肠埃希菌、肺炎克雷伯菌、铜绿假单胞菌、奇异变形杆菌和复合泄殖腔肠杆菌引起的成人复杂性尿路感染（cUTI），包括肾盂肾炎。2024 年 3 月，头孢吡肟/恩美沙唑巴坦在欧盟获批用于治疗成人 cUTI（包括肾盂肾炎）和医院获得性肺炎（包括呼吸机相关肺炎），以及治疗与上述任何一种感染相关或疑似相关的菌血症患者。本文总结了头孢吡肟/恩美沙唑巴坦在开发过程中取得的里程碑式进展，这些进展促成了头孢吡肟/恩美沙唑巴坦首次获批用于治疗由耐药革兰氏阴性菌引起的成人感染。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

期刊介绍： Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.

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