According to the European Medicines Agency (EMA), the drug Cefepim-Enmetazobactam (Exblifep) has been recommended for market approval for the treatment of adults with urinary tract infections (UTIs) and hospital-acquired pneumonia.
Exblifep is a combination of Cefepim, a fourth-generation cephalosporin, and Enmetazobactam, a novel beta-lactamase inhibitor with an expanded spectrum of activity. Cefepim exerts a bactericidal effect by inhibiting peptidoglycan cell wall synthesis, and Enmetazobactam binds to beta-lactamases, preventing the hydrolysis of Cefepim.
The Committee for Medicinal Products for Human Use (CHMP) of the EMA stated that the benefit for doctors and patients is that Exblifep has been proven to be as effective as Piperacillin-Tazobactam in treating complicated urinary tract infections, including pyelonephritis.
The announcement follows the results of the Phase 3 study
The announcement followed the results of the clinical Phase 3 study ALLIUM with Exblifep, which found that the overall efficacy for Exblifep was 79.1% compared to 58.9% for Piperacillin-Tazobactam (treatment difference 21.2%; 95% stratified Newcombe-CI 14.3%-27.9%).
The primary efficacy endpoint of the study, published in JAMA in October 2022, was defined as a combined successful outcome of symptom resolution and microbiological eradication in 1034 randomized patients (average age 54.7 years) at 112 sites in 19 countries.
Exblifep was found to be well-tolerated: 4.3% of patients reported serious adverse events, compared to 3.7% of patients receiving Piperacillin-Tazobactam.
Further investigations were recommended in the study to determine if Exblifep is suitable for treating complicated urinary tract infections and pyelonephritis.
In its recommendation, the CHMP stated that Exblifep is indicated for use in adults to treat the following:
- Complicated urinary tract infections, including pyelonephritis;
- Hospital-acquired pneumonia, including ventilator-associated pneumonia; or
- Bacteremia associated with or suspected to be related to any of the above infections.
The committee stated that official guidelines for the appropriate use of antibacterial agents should be considered.
The EMA summarized that the most common side effects of treatment with Exblifep were pain and inflammation at the infusion site, diarrhea, rash, and headaches.
Exblifep is available as 2g/0.5g powder for concentrate for solution for infusion.