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The European Medicines Agency (EMA) has recommended that the medicinal product cefepime-enmetazobactam (Exblifep) should be granted a marketing authorization for treating adults with urinary tract infections (UTIs) and hospital-acquired pneumonia.

Exblifep is a combination of cefepime, a fourth-generation cephalosporin, and enmetazobactam, a novel extended-spectrum beta-lactamase inhibitor. Cefepime exerts bactericidal activity by inhibiting peptidoglycan cell wall synthesis, and enmetazobactam binds to beta-lactamases and prevents hydrolysis of cefepime.

The EMA's Committee for Medicinal Products for Human Use (CHMP) said that the benefit for clinicians and patients was that Exblifep was found to be as effective as piperacillin-tazobactam in the treatment of complicated UTIs, including pyelonephritis.

Announcement Followed Phase 3 Trial Results

The announcement followed results from the phase 3 ALLIUM clinical trial of Exblifep, which found overall effectiveness was 79.1% for Exblifep vs 58.9% for piperacillin-tazobactam (treatment difference, 21.2%; 95% stratified Newcombe CI, 14.3%-27.9%).

The primary efficacy endpoint in the study, published in JAMA in October 2022, was defined as the composite success outcome of symptoms resolution and microbiological eradication in 1034 randomized patients (mean age, 54.7 years) at 112 sites in 19 countries.

Exblifep was found to be well tolerated, with 4.3% of patients reporting serious adverse events vs 3.7% of those receiving piperacillin-tazobactam. 

The trial recommended further research to determine whether Exblifep was suitable for treating complicated UTIs and pyelonephritis.

In its recommendation, the CHMP said that Exblifep was indicated in adults for the treatment of:

• Complicated urinary tract infections, including pyelonephritis;
• Hospital-acquired pneumonia, including ventilator-associated pneumonia; or
• Bacteremia that occurs in association with, or is suspected to be associated with, any of the above infections.

The committee stated that consideration should be given to official guidance on the appropriate use of antibacterial agents.

The most common side effects of treatment with Exblifep are pain and inflammation at the infusion site, diarrhea, skin rash, and headache, the EMA said in its summary.

Exblifep is available as a 2 g/0.5 g powder for concentrate for solution for infusion.