Venatorx Pharmaceuticals, based in Malvern, Pennsylvania, today announced that the US Food and Drug Administration (FDA) has accepted for priority review its cefepime-taniborbactam antibiotic combination for treating complicated urinary tract infections (cUTIs).
Cefepime-taniborbactam is an investigational intravenous (IV) beta-lactam/beta-lacatamase inhibitor antibiotic developed for adults with cUTI, including pyelonephritis. The drug has previously received FDA fast-track designation, and the FDA has set a target action date of February 22, 2024.
In a statement, Venatorx said its new drug application is supported by phase 3 study findings that evaluated the efficacy and safety of cefepime-taniborbactam compared to meropenem for treating cUTIs caused by extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales and carbapenem-resistant Enterobacterales. The drug was superior to meropenem for efficacy and was well tolerated, with no new safety issues.
Broad activity against key resistant pathogens
Paul McGovern, MD, the company's senior vice president, said cefepime-taniborbactam has broad-spectrum in vitro activity against established and rapidly increasing carbapenem resistance mechanisms such as serine- and metallo-beta-lactamases. He added that the drug, "if approved, will address a critical unmet need and be a potentially essential treatment option in the continuing fight against antimicrobial resistance in gram-negative bacterial infections."
If approved, [the drug] will address a critical unmet need and be a potentially essential treatment option in the continuing fight against antimicrobial resistance in gram-negative bacterial infections.
More specifically, the drug combo has shown in vitro activity against Centers for Disease Control and Prevention urgent and serious threat pathogens, including carbapenem-resistant Enterobacterales, ESBL-producing Enterobacterales, and multidrug-resistant Pseudomonas aeruginosa.
Venatorx is also evaluating cefepime-taniborbactam as a treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.