The US Food and Drug Administration (FDA) has accepted Venatorx Pharmaceuticals’ new drug application (NDA) for cefepime-taniborbactam antibiotic for the potential treatment of complicated urinary tract infections (cUTI) including pyelonephritis, in adults.
The regulatory agency has granted priority review for this NDA with Prescription Drug User Fee Act (PDUFA) target action date of 22 February next year.
It earlier granted Qualified Infectious Disease Product and Fast Track designations to cefepime-taniborbactam antibiotic.
The NDA is based on the results from the international, randomised, non-inferiority, active-controlled, double-blind, pivotal Phase III CERTAIN-1 study.
The trial compared the safety, efficacy, and tolerability of the investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic against meropenem in adults with cUTI, including including acute pyelonephritis.
A total of 661 adults were randomised into 2:1 ratio to receive 2.5g q8h antibiotic or 1g q8h meropenem intravenously for seven days, and up to 14 days for patients with bacteremia.
Cefepime-taniborbactam met the primary efficacy endpoint of statistical noninferiority (NI) against meropenem in the microbiological intent-to-treat (microITT) population at Test of Cure (TOC) visit from day 19-23.
Venatorx Pharmaceuticals Medical Sciences senior vice president Paul McGovern said: “Due to its broad spectrum of in-vitro activity against established and rapidly increasing mechanisms of carbapenem resistance such as serine- and metallo-beta-lactamases and the positive results demonstrated in CERTAIN-1, cefepime-taniborbactam, 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.
“Patients with cUTIs, including pyelonephritis, and their healthcare providers should have a new treatment option when confronted with infections due to these antibacterial resistant infections.”
Cefepime-taniborbactam is also being developed for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).