for complicated urinary tract infections
FDA approved Zaynich (cefepime + zidebactam) for adults with complicated urinary tract infections. Wockhardt's first FDA approval — gives clinicians a novel beta-lactam-enhancer combination for multidrug-resistant gram-negative cUTI.
Complicated urinary tract infections occur when structural issues or resistant bacteria make a common infection harder to treat. Zaynich combines the antibiotic cefepime with zidebactam, a compound that helps it overcome bacterial defenses. This pairing could provide a new treatment option for infections that have become resistant to many other antibiotics.
This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP
Source: ClinicalTrials.gov