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

The combination was approved for medical use in the United States in February 2024, and in the European Union in March 2024.

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.

In the EU, cefepime/enmetazobactam is indicated for the treatment of complicated urinary tract infections, including pyelonephritis; hospital-acquired pneumonia, including ventilator-associated pneumonia; 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.

History

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

Society and culture

Legal status

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

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. The applicant for this medicinal product is Advanz Pharma Limited. The combination was approved for medical use in the European Union in March 2024.

Names

The combination cefepime/enmetazobactam is sold under the brand name Exblifep.

References

1. ^ "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. ^ "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. ^ "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. 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

• 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

• 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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