Plazomicin Gets FDA OK for Adults in Treatment of cUTI

The US Food and Drug Administration (FDA, ) has approved plazomicin (Zemdri, Achaogen, Inc.) for the adults with complicated urinary tract infections (cUTI) including acute pyelonephritis, caused by certain Enterobacteriaceae, in patients with limited or no alternative treatment. 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®, Pharmacy Times' sister website.

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

“Plazomicin is a novel aminoglycoside antibiotic that has been modified to resist aminoglycoside modifying enzymes, but that gives it stability against common mechanisms of resistance among the Enterobacteriaceae against aminoglycosides.” described Dr Gallagher. “It is taking a structure that we have known for a long time, modifying it somewhat, to make it active against more resistant Enterobacteriaceae,” he added.

Additionally, plazomicin has in vitro activity against ESBL- producing, aminoglycoside- resistant, and carbapenem- resistant isolates.