FDA Approves Plazomicin for Treatment of Complicated Urinary Tract Infection

Officials with the FDA have approved plazomicin (Zemdri, Achaogen) for the treatment of adults with complicated urinary tract infections (cUTIs), caused by certain Enterobacteriaceae, in patients with limited or no alternative treatment. 

According to Achaogen, plazomicin has microbiological activity against pathogens including carbapenem-resistant (CRE) and extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae.

Plazomicin is the only once-daily aminoglycoside therapy approved for use in cUTI and is an intravenous infusion, administered once per day.

“Among the multidrug-resistant bacteria, gram-negatives are a most pressing concern. And, of that, there are different issues with the different species that we see causing antibiotic resistance,” stressed Jason Gallagher, PharmD, clinical professor, Temple University School of Pharmacy, who serves as editor-in-chief of Contagion®, Specialty Pharmacy Times' sister website.

In phase 3 clinical trial, Evaluating Plazomicin in cUti (EPIC), plazomicin demonstrated non-inferiority to meropenem for the co-primary efficacy endpoints of composite cure in the microbiological modified intent to treat population in the treatment of adult patients with cUTI.

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