The Food and Drug Administration is speeding up the review process for an antibiotic combination that’s used to treat complicated urinary tract infections, or cUTIs.
The FDA will give priority review for a cefepime-taniborbactam antibiotic combination made by Venatorx Pharmaceuticals.
Cefepime-taniborbactam is an investigational medication that is given intravenously. It’s a beta-lactam/beta-lacatamase inhibitor antibiotic. Beta-lactamase inhibitors are drugs given in conjunction with beta-lactam antimicrobials in an effort to prevent antimicrobial resistance.
The medication is made for adults with cUTI. It also treats pyelonephritis, a bacterial infection that inflames the kidneys.
The medication already got fast-track designation from the FDA. The FDA expects to take action on the review around February 22, 2024.
In a statement, Venatorx said the priority review comes after phase 3 trials that compared cefepime-taniborbactam compared to meropenem for treating cUTIs caused by extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales and carbapenem-resistant Enterobacterales. The drug worked better than meropenem and people tolerated it well. There were no safety issues reported in people who took it.
“If approved, it 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.” Paul McGovern, MD, the company’s senior vice president, said. Cefepime-taniborbactam has broad-spectrum in vitro activity against existing and quickly carbapenem resistance mechanisms such as serine- and metallo-beta-lactamases. It’s shown some promise to fight urgent and serious threat pathogens as designated by the CDC. These include carbapenem-resistant Enterobacterales, ESBL-producing Enterobacterales, and multidrug-resistant Pseudomonas aeruginosa.
