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 bacteria infect the urinary system in people with underlying health issues or catheters, and they are increasingly hard to treat due to multi-drug resistant germs. Zaynich is a two-drug combination where cefepime attacks the bacteria's cell wall and zidebactam acts as a shield, disabling the bacterial enzymes that would normally destroy the antibiotic. This dual action restores the power of the main antibiotic, potentially offering an effective treatment option for these serious, resistant infections.
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