Cefepime and taniborbactam FDA Approval Status
Last updated by Judith Stewart, BPharm on Sep 5, 2023.
FDA Approved: No
Generic name: cefepime and taniborbactam
Company: Venatorx Pharmaceuticals
Treatment for: Urinary Tract Infection
Cefepime-taniborbactam is an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic in development for the potential treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis.
- Complicated UTIs, which include pyelonephritis, are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms, including fever, chills, malaise, flank pain, back pain, and/or costovertebral angle pain or tenderness.
- Cefepime-taniborbactam contains cefepime, a widely used fourth-generation cephalosporin beta-lactam antibiotic, and taniborbactam, a beta-lactamase inhibitor. The cefepime-taniborbactam combination is being studied as a potential treatment for patients with serious bacterial infections caused by antibiotic resistant gram-negative bacteria, including extended spectrum beta-lactamase (ESBL)-expressing Enterobacterales, carbapenem-resistant Enterobacterales (CRE), and multidrug-resistant (MDR) Pseudomonas aeruginosa (MDR-PA), which can include carbapenem-resistant P. aeruginosa (CRPA).
- The cefepime-taniborbactam New Drug Application (NDA) is supported by results from the CERTAIN-1 pivotal Phase 3 study which evaluated the efficacy and safety of cefepime-taniborbactam compared to meropenem in adults with cUTI, including acute pyelonephritis. 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. Cefepime-taniborbactam was well-tolerated and no new safety findings were identified.
- Cefepime-taniborbactam is administered by intravenous injection.
- On February 23, 2024, Venatorx Pharmaceuticals and Melinta Therapeutics announced the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for cefepime-taniborbactam. The CRL did not identify clinical safety or efficacy issues in the NDA, and the FDA did not request any new clinical trials to support the approval of cefepime-taniborbactam. The FDA requested additional chemistry, manufacturing, and controls (CMC) and related data about the drug, testing methods, and manufacturing process.
Development timeline for cefepime and taniborbactam
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
