External links
- Clinical trial number NCT03687255 for "Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections" at ClinicalTrials.gov
| 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]
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]
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]
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]
Enmetazobactam was invented by Orchid Pharma in India and then out-licensed to Allecra Therapeutics for further development. [6]
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]
The combination cefepime/enmetazobactam is sold under the brand name Exblifep. [1] [2]
