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- Title
Cefepime/Enmetazobactam: First Approval.
- Authors
Keam, Susan J.
- 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.
- Subjects
URINARY tract infections; PNEUMONIA; BACTEREMIA; CEFEPIME; VENTILATOR-associated pneumonia; PYELONEPHRITIS; NOSOCOMIAL infections; MOLECULAR structure; GRAM-negative bacteria
- Publication
Drugs, 2024, Vol 84, Issue 6, p737
- ISSN
0012-6667
- Publication type
Article
- DOI
10.1007/s40265-024-02035-2