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.