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Venatorx, Everest Medicines Accept New Drug Application for Cefepime-Taniborbactam

Wednesday, August 16, 2023

Venatorx Pharmaceuticals, in collaboration with Everest Medicines, has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for cefepime-taniborbactam. 

This investigative beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic holds potential for treating adults with complicated urinary tract infections (cUTI), encompassing pyelonephritis.

The NDA submission for cefepime-taniborbactam is substantiated by data from the pivotal Phase 3 trial, CERTAIN-1. This study assessed the efficacy and safety of cefepime-taniborbactam in comparison to meropenem among adults with cUTI, including acute pyelonephritis. Cefepime-taniborbactam demonstrated favourable tolerability and revealed no new safety concerns.

Cefepime, a fourth-generation cephalosporin, boasts over two decades of established safety and clinical efficacy as a beta-lactam (BL) antibiotic. It has proven effective against susceptible gram-negative and gram-positive bacteria.

Taniborbactam, a beta-lactamase inhibitor (BLI), is being explored in conjunction with cefepime as a potential solution for patients grappling with severe bacterial infections caused by antibiotic-resistant gram-negative bacteria.

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