Plazomicin Approved By FDA for Adults in Treatment of cUTI
JUN 26, 2018 | MICHAELA FLEMING
The US Food and Drug Administration (FDA) has approved plazomicin (ZEMDRI) for adults with complicated urinary tract infections (cUTI) including acute pyelonephritis, caused by certain Enterobacteriaceae, in patients with limited or no options for alternative treatment. Plazomicin is the only once-daily aminoglycoside therapy approved for use in cUTI and is an intravenous infusion. The drug was developed by Achaogen, Inc, who mission is to develop innovative antibacterial agents to address multidrug-resistant gram-negative infections.
“Among the multidrug-resistant bacteria, gram-negatives are a most pressing concern," stressed Jason Gallagher, PharmD, clinical professor, Temple University School of Pharmacy, editor-in-chief of Contagion®, in a recent interview. "And there are different issues with the different species that we see causing antibiotic resistance."
Plazomicin has microbiological activity against pathogens including carbapenem-resistant (CRE) and extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae, according to Achaogen.
“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.” Dr Gallagher explained. “So, it is taking a structure that we have known for a long time, modifying it somewhat, to make it active against more resistant Enterobacteriaceae."
Additionally, plazomicin has been shown to have in vitro activity against ESBL- producing, aminoglycoside-resistant, and carbapenem-resistant isolates.
Dr Gallagher explained the clinical implications of plazomicin for health care providers and patients in a recent interview (see video below ).
In the 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.
"Bacteria continue to circumvent existing antibiotics, making certain infections notoriously hard to treat and putting some patients at high risk for mortality," said James A. McKinnell, assistant professor of medicine at the David Geffen School of Medicine and LA Biomed at Harbor-UCLA in an official statement. "Aminoglycosides are a familiar and very effective class of antibiotics. I look forward to adding plazomicin to my short list of available treatment options and to its potential impact on patient outcomes."
Plazomicin is indicated in patients aged 18 or older for cUTIs and pyelonephritis caused by Escherichia coli, Klebsiella pneumonia, Proteus mirabilis, and Enterobacter cloacae.
The FDA has issued a complete response letter that the clinical trial, CARE does not provide substantial evidence of effectiveness for plazomicin in the treatment of bloodstream infections. In May, it was reported that the FDA Advisory Committee 11 of the 15 members of the committee voted that there was not substantial evidence for the safety and effectiveness of plazomicin for the treatment of bloodstream infections in patients with limited treatment options.
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