IDStewardship

Cefepime-Taniborbactam

cefepime-taniborbactam photo pending

Unfortunate news as cefepime-taniborbactam failed to achieve FDA-approval in February 2024, FDA requested additional chemistry, manufacturing, and controls (CMC) and related data about the drug, testing methods, and manufacturing process…

If cefepime-taniborbactam is FDA approved this page will be updated.

KEY POINTS

  • Cefepime is a fourth-generation cephalosporin and beta-lactam antibiotic
  • Taniborbactam is a boronic acid containing beta-lacatamase inhibitor
    • Taniborbactam has been shown to be able to inhibit enzyme from Ambler class A, B, C, and D
      • Class B enzymes are a major area of need and taniborbactam can inhibit VIM, NDM, SPM-1, and GIM-1 (but not IMP)
  • Adding taniborbactam as a beta-lactamase to cefepime can expand the actvitity of cefepime by preventing it’s degradation by beta-lactamase enzymes certain drug-resistant bacteria produce
    • Cefepime-taniborbactam may be an option versus carbapenem-resistant Enterobacterales or Pseudomonas aeruginosa, including some bacteria that are resistant to ceftazidime-avibactam (Avycaz)
  • Not FDA approved for any indication as of August 2023
    • Has an NDA that has been accepted by the FDA as of August 2023
    • Being investigated by Venatorx Pharma
      • Being studied versus meropenem for complicated urinary tract infections (cUTIs) – (CERTAIN-1 study)
      • Being studied for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) – (CERTAIN-2 study)
    • Potential FDA approval is anticipated for early 2024 at earliest, if it progresses to being approved #BadBugsNeedDrugs

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