FDA Approves Cefepime-Zidebactam Injection - Summary - MDSpire

FDA Approves Cefepime-Zidebactam Injection

Phase 3 ENHANCE-1 results showed higher composite clinical cure and microbiologic response rates with cefepime-zidebactam vs meropenem in hospitalized adults with complicated urinary tract infection or acute pyelonephritis.

  • By

  • Kathryn Wighton

  • June 3, 2026

  • 2 min

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Objective:

To announce the FDA approval of cefepime and zidebactam for treating complicated urinary tract infections in adults, as stated in a Wockhardt press release.

Key Findings:
  • Cefepime and zidebactam achieved a composite clinical cure and microbiologic response rate of 89% at the test-of-cure visit, as reported by Wockhardt.
  • This rate was significantly higher compared to 68% for meropenem, according to Wockhardt.
  • The treatment was generally well tolerated, as stated in the Wockhardt press release.
Interpretation:

Cefepime and zidebactam combines a fourth-generation cephalosporin with a non-beta-lactam antibacterial and beta-lactamase inhibitor, acting synergistically.

Limitations:
  • The study was limited to patients with complicated urinary tract infections or acute pyelonephritis, as noted by Wockhardt.
Conclusion:

Cefepime and zidebactam is indicated for infections caused by susceptible strains of specific Gram-negative pathogens, according to Wockhardt.

Original Source(s)

FDA Approves Cefepime-Zidebactam Injection

  • by Kathryn Wighton

  • June 3, 2026

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