Cefepime/enmetazobactam
Combination of | |
---|---|
beta-lactamase inhibitor | |
Clinical data | |
Trade names | Exblifep |
License data | |
Intravenous | |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
KEGG |
Cefepime/enmetazobactam, sold under the brand name Exblifep, is a
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
In the US, cefepime/enmetazobactam is
In the EU, cefepime/enmetazobactam is indicated for the treatment of complicated urinary tract infections, including pyelonephritis;
History
Enmetazobactam was invented by Orchid Pharma in India and then out-licensed to Allecra Therapeutics for further development.[5]
Society and culture
Legal status
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]
References
- ^ 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
- 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. 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. 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