FDA Accepts NDA for Venatorx Pharmaceuticals’ Cefepime-Taniborbactam for Complicated UTIs

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The Prescription Drug User Fee Act (PDUFA) action date is scheduled for the first quarter of 2024.

The FDA has accepted the company’s New Drug Application (NDA) for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic for the potential treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis.

“The NDA acceptance represents the culmination of unwavering dedication, scientific excellence, and the collaborative efforts of our talented team, partners, and clinical investigators,” Venatorx CEO Christopher J. Burns, PhD, said in a statement. “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.”

The PDUFA target action date is set for February 22, 2024.

In previous reporting by Contagion, the company offered insights on its phase 3 CERTAIN-1 study, which demonstrated cefepime-taniborbactam was superior to meropenem for the primary efficacy endpoint of composite microbiologic and clinical success at the Test of Cure (TOC) visit (Day 19-23) in the microbiological intent-to-treat (microITT) population.

At end of treatment (Day 7-14), response rates were 89.1% for cefepime-taniborbactam and 86% for meropenem, and at Day 28-35 they were 63.8% and 51.7% respectively.

The study included 661 hospitalized patients with complicated urinary tract infections, including acute pyelonephritis, receiving either 2.5 g of cefepime-taniborbactam or 1 g of meropenem every eight hours. The average age of study participants was 56.2 and 52.8% were female.

Cefepime-taniborbactam was well-tolerated and no new safety findings were identified. Treatment-emergent adverse events occurred in 35.5% of patients in the cefepime-taniborbactam group and 29% of patients in the meropenem group, including headache, diarrhea, constipation, hypertension, and nausea.

“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,” Venatorx Senior Vice President, Medical Sciences, Paul McGovern, MD, said in a statement.

Watch this Contagion interview with Burns back in 2021 about innovation in antibiotic development as well as more information on cefepime-taniborbactam.

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