Europe Approves Exblifep for UTIs and Pneumonia

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.

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%).

Source: MEDspace