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Drugs

18.05.2024 | ADISINSIGHT REPORT

Cefepime/Enmetazobactam: First Approval

verfasst von: Susan J. Keam

Erschienen in: Drugs

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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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Literatur
1.
Papp-Wallace KM, Bethel CR, Caillon J, et al. Beyond piperacillin-tazobactam: cefepime and AAI101 as a potent β-lactam-β-lactamase inhibitor combination. Antimicrob Agents Chemother. 2019;63(5):e00105-e119.CrossRefPubMedPubMedCentral
2.
Belley A, Morrissey I, Hawser S, et al. Third-generation cephalosporin resistance in clinical isolates of Enterobacterales collected between 2016–2018 from USA and Europe: genotypic analysis of β-lactamases and comparative in vitro activity of cefepime/enmetazobactam. J Glob Antimicrob Resist. 2021;25:93–101.CrossRefPubMed
3.
Kaye KS, Belley A, Barth P, et al. Effect of cefepime/enmetazobactam vs piperacillin/tazobactam on clinical cure and microbiological eradication in patients with complicated urinary tract infection or acute pyelonephritis: a randomized clinical trial. JAMA. 2022;328(13):1304–14.CrossRefPubMedPubMedCentral
4.
Isler B, Harris P, Stewart AG, Paterson DL. An update on cefepime and its future role in combination with novel β-lactamase inhibitors for MDR Enterobacterales and Pseudomonas aeruginosa. J Antimicrob Chemother. 2021;76(3):550–60.CrossRefPubMed
5.
Magill SS, O’Leary E, Ray SM, et al. Antimicrobial use in US hospitals: comparison of results from emerging infections program prevalence surveys, 2015 and 2011. Clin Infect Dis. 2021;72(10):1784–92.CrossRefPubMed
6.
Advani SD, Claeys K. Cefepime/enmetazobactam for complicated urinary tract infections. JAMA. 2022;328(13):1299–301.CrossRefPubMed
7.
Vázquez-Ucha JC, Lasarte-Monterrubio C, Guijarro-Sánchez P, et al. Assessment of activity and resistance mechanisms to cefepime in combination with the novel β-lactamase inhibitors zidebactam, taniborbactam, and enmetazobactam against a multicenter collection of carbapenemase-producing Enterobacterales. Antimicrob Agents Chemother. 2022;66(2): e0167621.CrossRefPubMed
8.
9.
10.
Allecra Therapeutics. Allecra Therapeutics announces US FDA approval for EXBLIFEP® for the treatment of complicated urinary tract infections [media release]. 27 Feb 2024. https://​www.​allecra.​com. Accessed 27 Feb 2024.
11.
12.
ADVANZ PHARMA Limited, Allecra Therapeutics. ADVANZ PHARMA and Allecra Therapeutics announce approval in the European Union for the new antibiotic combination EXBLIFEP® (cefepime/enmetazobactam) for the treatment of severe infections [media release]. 27 Mar 2024. https://​www.​advanzpharma.​com/​. Accessed 27 Mar 2024.
13.
14.
Allecra Therapeutics. Allecra Therapeutics and ADVANZ PHARMA sign exclusive license and supply agreement for Allecra’s antibiotic cefepime/enmetazobactam in Europe [media release]. 13 Jan 2022. https://​www.​allecra.​com. Accessed 13 Jan 2022.
15.
Allecra Therapeutics GmbH, Shanghai Haini Pharmaceutical Co Ltd. Allecra Therapeutics and Shanghai Haini Pharmaceutical announce exclusive licensing agreement for cefepime/enmetazobactam for Greater China [media release]. 21 Dec 2020. https://​www.​allecra.​com. Accessed 21 Dec 2020.
16.
Orchid Chemicals & Pharmaceuticals. Orchid enters into strategic partnership with Allecra Therapeutics for development of novel antibiotics [media release]. 18 Apr 2013. https://​www.​orchidpharma.​com. Accessed 18 Apr 2013.
17.
Principe L, Lupia T, Andriani L, et al. Microbiological, clinical, and PK/PD features of the new anti-Gram-negative antibiotics: β-lactam/β-lactamase inhibitors in combination and cefiderocol—an all-inclusive guide for clinicians. Pharmaceuticals (Basel). 2022;15:463.CrossRefPubMed
18.
Morrissey I, Magnet S, Hawser S, et al. In vitro activity of cefepime-enmetazobactam against Gram-negative isolates collected from US and European hospitals during 2014–2015. Antimicrob Agents Chemother. 2019;63(7):e00514-e519.CrossRefPubMedPubMedCentral
19.
Tselepis L, Langley GW, Aboklaish AF, et al. In vitro efficacy of imipenem-relebactam and cefepime-AAI101 against a global collection of ESBL-positive and carbapenemase-producing Enterobacteriaceae. Int J Antimicrob Agents. 2020;56(1): 105925.CrossRefPubMed
20.
Hawser S, Morrissey I, Kothari N, et al. Influence of genotype on the activity of cefepime/enmetazobactam against beta-lactam resistant Enterobacterales collected from Europe in 2019-2021 [abstract and poster no. P0097]. In: 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). 2023.
21.
Knechtle P, Shapiro S, Morrissey I, et al. Sigmoid Emax modeling to define the fixed concentration of enmetazobactam for MIC testing in combination with cefepime. Antimicrob Agents Chemother. 2021;65(8): e0092621.CrossRefPubMed
22.
Belley A, Kothari N, Monti F, et al. Antibacterial activity of cefepime/enmetazobactam and comparator agents against US enterobacterales clinical isolates collected from 2019–2021. Open Forum Infect Dis. 2023;10(Suppl 2):S60–70.
23.
Hawser S, Morrissey I, Kothari N, et al. Surveillance of cefepime/enmetazobactam against European isolates of Enterobacterales collected between 2019 and 2021, including cephalosporin-resistant phenotypes [Abstract and poster no. P0289]. In: 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). 2023.
24.
Crandon JL, Nicolau DP. In vivo activities of simulated human doses of cefepime and cefepime-AAI101 against multidrug-resistant Gram-negative Enterobacteriaceae. Antimicrob Agents Chemother. 2015;59(5):2688–94.CrossRefPubMedPubMedCentral
25.
Bernhard F, Odedra R, Sordello S, et al. Pharmacokinetics-pharmacodynamics of enmetazobactam combined with cefepime in a neutropenic murine thigh infection model. Antimicrob Agents Chemother. 2020;64(6):e00078-e120.CrossRefPubMedPubMedCentral
26.
Johnson A, McEntee L, Farrington N, et al. Pharmacodynamics of cefepime combined with the novel extended-spectrum-β-lactamase (ESBL) inhibitor enmetazobactam for murine pneumonia caused by ESBL-producing Klebsiella pneumoniae. Antimicrob Agents Chemother. 2020;64(6):e00180-e220.CrossRefPubMedPubMedCentral
27.
Das S, Fitzgerald R, Ullah A, et al. Intrapulmonary pharmacokinetics of cefepime and enmetazobactam in healthy volunteers: towards new treatments for nosocomial pneumonia. Antimicrob Agents Chemother. 2020;65(1):e01468-e1520.CrossRefPubMedPubMedCentral
28.
Carmeli Y, Knechtle P, Hardenberg J, et al. A randomized phase 2 study of cefepime combined with the novel extended spectrum β-lactamase inhibitor enmetazobactam in hospitalized adults with complicated urinary tract infections (cUTI) including acute pyelonephritis (AP) [abstract no 1479]. OFID. 2019;6(Suppl 2):S539.CrossRefPubMedCentral
Metadaten
Titel
Cefepime/Enmetazobactam: First Approval
verfasst von
Susan J. Keam
Publikationsdatum
18.05.2024
Verlag
Springer International Publishing
Erschienen in
Drugs
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-024-02035-2