Cefepime-Taniborbactam Gets Priority Review for Complicated UTI

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for cefepime-taniborbactam for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis.

Cefepime-taniborbactam is an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic. The Company believes that the combination may provide another therapeutic option for difficult-to-treat drug resistant gram-negative bacteria, such as carbapenem-resistant Enterobacterales and carbapenem-resistant Pseudomonas aeruginosa.

The NDA is supported by data from the pivotal randomized, double-blind, active-controlled, phase 3 CERTAIN-1 study (ClinicalTrials.gov Identifier: NCT03840148) that compared the efficacy and safety of cefepime-taniborbactam to meropenem in adults with cUTI, including acute pyelonephritis. Study participants were randomly assigned 2:1 to receive cefepime-taniborbactam 2.5mg intravenously (IV) every 8 hours or meropenem 1g IV every 8 hours for 7 days (up to 14 days for patients with bacteremia). 

The primary endpoint was the composite of clinical and microbiologic response (eg, bacterial eradication) at the test of cure (TOC) visit (days 19 to 23) in the microbiological intent-to-treat (microITT) population.

Findings showed that cefepime-taniborbactam met the primary endpoint achieving statistical noninferiority to meropenem at the TOC visit in the microITT population. Composite microbiologic and clinical success occurred in 70.6% of patients treated with cefepime-taniborbactam vs 58% of patients treated with meropenem (treatment difference 12.6%; 95% CI, 3.1-22.2). Moreover, cefepime-taniborbactam achieved statistical superiority to meropenem for the composite endpoint at TOC (2-sided P =.0088), which was sustained at the Late-Follow-Up visit (days 28-35).

Treatment-emergent adverse events occurred in 35.5% of patients treated with cefepime-taniborbactam and 29% of patients treated with meropenem. Serious TEAEs occurred in 2% of patients treated with cefepime-taniborbactam and 1.8% of patients treated with meropenem.

A Prescription Drug User Fee Act target date of February 22, 2024 has been set for this application.

“The NDA acceptance represents the culmination of unwavering dedication, scientific excellence, and the collaborative efforts of our talented team, partners, and clinical investigators,” said Christopher J. Burns, PhD, CEO of Venatorx. “Cefepime-taniborbactam exemplifies our commitment to innovation and improving patient outcomes. By addressing the evolving and increasing challenges posed by antimicrobial resistance, we aim to make a meaningful impact on global public health.”