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]
| 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 | |
The combination was approved for medical use in the United States in February 2024,[1][4] and in the European Union in March 2024.[2][3]
Medical uses
editIn 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]
History
editEnmetazobactam was invented by Orchid Pharma in India and then out-licensed to Allecra Therapeutics for further development.[5]
Society and culture
editLegal status
editIn 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]
References
edit- ^ a b c d "Exblifep- cefepime hydrochloride, enmetazobactam injection, powder, for solution". DailyMed. 28 February 2024. Archived from the original on 11 March 2024. Retrieved 11 March 2024.
- ^ a b c d e f g h i j "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.
- ^ a b c "Exblifep Product information". Union Register of medicinal products. 23 March 2024. Archived from the original on 26 March 2024. Retrieved 1 April 2024.
- ^ "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.
- ^ 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
edit- Kaye KS, Belley A, Barth P, Lahlou O, Knechtle P, Motta P, et al. (October 2022). "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. 328 (13): 1304–1314. doi:10.1001/jama.2022.17034. PMC 9533186. PMID 36194218.
- Papp-Wallace KM (December 2019). "The latest advances in β-lactam/β-lactamase inhibitor combinations for the treatment of Gram-negative bacterial infections". Expert Opinion on Pharmacotherapy. 20 (17): 2169–2184. doi:10.1080/14656566.2019.1660772. PMC 6834881. PMID 31500471.
- US 7687488, issued 2010-03-30
External links
edit- Clinical trial number NCT03687255 for "Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections" at ClinicalTrials.gov
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