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Drugs. 2024 Jun;84(6):737-744. doi: 10.1007/s40265-024-02035-2. Epub 2024 May 18.
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.
头孢吡肟/恩他唑巴坦（EXBLIFEP）是一种第四代头孢菌素和扩展谱β-内酰胺酶（ESBL）抑制剂的静脉注射（IV）抗菌固定剂量组合，由 Allecra Therapeutics 和 ADVANZ PHARMA 开发，用于治疗由多药耐药（MDR）革兰氏阴性菌引起的感染。2024 年 2 月，头孢吡肟/恩他唑巴坦在美国获得批准，用于治疗敏感株大肠埃希菌、肺炎克雷伯菌、铜绿假单胞菌、奇异变形杆菌和阴沟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/恩他唑巴坦在欧盟获得批准，用于治疗成人复杂性尿路感染（cUTI），包括肾盂肾炎，以及医院获得性肺炎，包括呼吸机相关性肺炎，并用于治疗与这些感染相关或疑似相关的菌血症患者。本文总结了头孢吡肟/恩他唑巴坦开发过程中的里程碑事件，最终该药获得批准，用于治疗由 MDR 革兰氏阴性菌引起的成人感染。
