FDA Approves Combination Antibiotic for Treatment of Complicated Urinary Tract Infections

This article first appeared on our sister site, Contemporary OB/GYN.

The investigational combination antibiotic, cefepime-enmetazobactam (Exblifep; Orchid Pharma) was granted FDA approval for treating cUTI in adults after demonstrating superiority over piperacillin-tazobactam in clinical cure and microbiological eradication in a global phase 3 trial.1

Coincidentally, the federal agency issued a complete response letter for another combination antibiotic, cefepime-taniborbactam, for the treatment of cUTI on the same day.

The cefepime-enmetazobactam approval is based from the data of a randomized, controlled, double-blind, late stage trial treating cUTI.2 The fourth-generation cephalosporin cefepime and proprietary beta lactamase inhibitor combination was developed to fight antimicrobial resistance in gram-negative bacteria. Non-inferiority and superiority criteria for clinical cure and microbiological eradication were observed when comparing cefepime-enmetazobactam to piperacillin-tazobactam.

Complicated UTI requiring therapy is reported in approximately 3.6 million patients in the US annually, and results in over 626,000 hospitalizations for the condition.3 Symptoms of cUTI include chills, fever, back pain, flank pain, costo-vertebral angle pain or tenderness, and malaise. Intravenous treatment is often employed to manage cUTI.

Acute pyelonephritis is reported in 15 to 17 female patients per year in the United States. It is caused by an ascending UTI from the bladder to the kidneys, leading to inflammation. Pyelonephritis was included among the cUTIs evaluated in the phase 3 trial.

In the phase 3 trial, 1034 participants were randomized to receive cefepime 2 g and enmetazobactam 0.5 g or piperacillin 4 g and tazobactam 0.5 g through 2 hours of continuous intravenous infusion every 8 hours. Clinical cure was defined as symptoms resolution, and microbiological eradications as under 103 CFU/mL in urine culture.

Efficacy was evaluated in patients with a gram-negative pathogen infection deemed non-resistant to cefepime-enmetazobactam and piperacillin-tazobactam. Cefepime-enmetazobactam had a success rate of 79.1% while piperacillin-tazobactam had a success rate of 58.9%.

Treatment discontinuation was observed in 5.2% and 4% of patients taking cefepime-enmetazobactam and piperacillin-tazobactam, respectively.

The FDA approval will allow cefepime-enmetazobactam to be introduced in the US market, and is expected to launch in the country within the next few quarters.1


  1. Orchid Pharma gets USFDA approval for Exblifep. Express Pharma. February 23, 2024. Accessed February 23, 2024. https://www.expresspharma.in/orchid-pharma-gets-usfda-approval-for-exblifep/
  2. Allecra Therapeutics submits New Drug Application to the US FDA for EXBLIFEP for the treatment of complicated urinary tract infections. Business Wire. June 27, 2023. Accessed February 23, 2024. https://www.businesswire.com/news/home/20230627361506/en/Allecra-Therapeutics-Submits-New-Drug-Application-to-the-U.S.-FDA-for-EXBLIFEP%C2%AE-for-the-Treatment-of-Complicated-Urinary-Tract-Infections
  3. Allecra Therapeutics announces positive top-line results for phase 3 ALLIUM clinical trial of EXBLIFEP for complicated Urinary Tract Infections. Allecra Therapeutics. February 25, 2020. Accessed February 23, 2024. https://www.globenewswire.com/news-release/2020/02/25/1989893/0/en/Allecra-Therapeutics-Announces-Positive-Top-Line-Results-for-Phase-3-ALLIUM-Clinical-Trial-of-EXBLIFEP-for-Complicated-Urinary-Tract-Infections.html

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