FDA Approves Cefepime-Zidebactam Injection - Summary - MDSpire
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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.
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.
