Cefepime/enmetazobactam

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Cefepime/enmetazobactam
Combination of
Cefepime cephalosporin
Enmetazobactam beta-lactamase inhibitor
Clinical data
Trade names Exblifep
AHFS/Drugs.com Monograph
License data
Routes of
administration 		Intravenous
ATC code
Legal status
Legal status
Identifiers
KEGG

Cefepime/enmetazobactam, sold under the brand name Exblifep, is a medication used for the treatment of urinary tract infections. [1] [2] It is a fixed dose combination containing cefepime, a cephalosporin antibacterial; and enmetazobactam, a beta-lactamase inhibitor. [2]

Contents

The combination was approved for medical use in the United States in February 2024, [1] [4] [5] and in the European Union in March 2024. [2] [3]

Medical uses

In the US, cefepime/enmetazobactam is indicated for the treatment of people with complicated urinary tract infections including pyelonephritis, caused by the following susceptible microorganisms: Escherichia coli , Klebsiella pneumoniae , Pseudomonas aeruginosa , Proteus mirabilis , and Enterobacter cloacae complex. [1] [6]

In the EU, cefepime/enmetazobactam is indicated for the treatment of complicated urinary tract infections, including pyelonephritis; [2] hospital-acquired pneumonia, including ventilator-associated pneumonia; [2] and the treatment of people with bacteremia that occurs in association with, or is suspected to be associated with, any of the infections listed above. [2]

History

Enmetazobactam was invented by Orchid Pharma in India and then out-licensed to Allecra Therapeutics for further development. [7]

Society and culture

The combination was approved for medical use in the United States in February 2024. [1]

In January 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Exblifep, intended for the treatment of urinary tract infections and pneumonia in adults. [2] The applicant for this medicinal product is Advanz Pharma Limited. [2] The combination was approved for medical use in the European Union in March 2024. [2] [3]

Names

The combination cefepime/enmetazobactam is sold under the brand name Exblifep. [1] [2]

References

  1. 1 2 3 4 5 6 "Exblifep- cefepime hydrochloride, enmetazobactam injection, powder, for solution". DailyMed. 28 February 2024. Archived from the original on 11 March 2024. Retrieved 11 March 2024.
  2. 1 2 3 4 5 6 7 8 9 10 11 "Exblifep EPAR". European Medicines Agency (EMA). 25 January 2024. Archived from the original on 4 February 2024. Retrieved 3 February 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  3. 1 2 3 "Exblifep Product information". Union Register of medicinal products. 23 March 2024. Archived from the original on 26 March 2024. Retrieved 1 April 2024.
  4. ↑ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.
  5. ↑ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
  6. ↑ "Drug Trials Snapshots: Exblifep". U.S. Food and Drug Administration. 22 February 2024. Retrieved 2 June 2025.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  7. ↑ US patent No.7687488B2 Novel 2-substituted methyl penam derivatives, https://worldwide.espacenet.com/patent/search/family/038949982/publication/US7687488B2?q=pn%3DUS7687488 Archived 5 April 2024 at the Wayback Machine

Further reading

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