Cefepime/enmetazobactam explained

Type:combo
Component1:Cefepime
Class1:cephalosporin
Component2:Enmetazobactam
Class2:beta-lactamase inhibitor
Tradename:Exblifep
Dailymedid:Cefepime hydrochloride, enmetazobactam
Routes Of Administration:Intravenous
Atc Prefix:J01
Atc Suffix:DE51
Legal Us:Rx-only
Legal Us Comment:[1]
Legal Eu:Rx-only
Legal Eu Comment:[2]
Kegg:D12818

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,[3] 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.[4]

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. The applicant for this medicinal product is Advanz Pharma Limited.[5] The combination was approved for medical use in the European Union in March 2024.

Further reading

Notes and References

  1. Web site: Exblifep- cefepime hydrochloride, enmetazobactam injection, powder, for solution . DailyMed . 28 February 2024 . 11 March 2024 . 11 March 2024 . https://web.archive.org/web/20240311071906/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2da031b1-07ff-48f3-88d2-7e86ba93048a . live .
  2. Web site: Exblifep Product information . Union Register of medicinal products . 23 March 2024 . 1 April 2024 . 26 March 2024 . https://web.archive.org/web/20240326155137/https://ec.europa.eu/health/documents/community-register/html/h1794.htm . live .
  3. Web site: Novel Drug Approvals for 2024 . U.S. Food and Drug Administration (FDA) . 29 April 2024 . 30 April 2024 . 30 April 2024 . https://web.archive.org/web/20240430031024/https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024 . live .
  4. US patent No.7687488B2 Novel 2-substituted methyl penam derivatives, https://worldwide.espacenet.com/patent/search/family/038949982/publication/US7687488B2?q=pn%3DUS7687488
  5. Web site: Exblifep EPAR . European Medicines Agency (EMA) . 25 January 2024 . 3 February 2024 . 4 February 2024 . https://web.archive.org/web/20240204141523/https://www.ema.europa.eu/en/medicines/human/EPAR/exblifep . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Cefepime/enmetazobactam".

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