FDA Approves Cefepime-Zidebactam Injection - Takeaways - 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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  • 1

    The FDA approved cefepime and zidebactam for treating complicated urinary tract infections in adults.

  • 2

    The approval is based on the phase 3 ENHANCE-1 trial, which involved 530 patients across multiple countries.

  • 3

    Cefepime and zidebactam achieved a composite clinical cure rate of 89%, compared to 68% for meropenem.

  • 4

    The treatment combines a fourth-generation cephalosporin with a non-beta-lactam antibacterial and beta-lactamase inhibitor.

  • 5

    Cefepime and zidebactam received Priority Review, Fast Track, and Qualified Infectious Disease Product designations from the FDA.

Original Source(s)

FDA Approves Cefepime-Zidebactam Injection

  • by Kathryn Wighton

  • June 3, 2026

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