The Center for Devices and Radiological Health of the US FDA has issued clearance for the Thermo Scientific QMS Plazomicin Immunoassay.
The Center for Devices and Radiological Health of the US Food and Drug Administration (FDA) issued clearance for the Thermo Scientific QMS Plazomicin Immunoassay, Achaogen Inc., announced today.
The immunoassay uses automated clinical chemistry analyzers to provide a quantitative measure of plazomicin in human plasma.
“Therapeutic drug monitoring is recommended for patients with a creatinine clearance (CrCl) between 15 mL/min and 90 mL/min receiving plazomicin. A reliable, commercially available assay will enable wider safe utilization of this important medication,” Monica V. Mahoney, PharmD, BCPS-AQ ID, a Contagion® Editorial Board member from Beth Israel Deaconess Medical Center in Boston, Massachusetts, said in an interview.
The assay was developed through a collaboration between Achaogen and Thermo Fisher Scientific with the goal of assisting clinicians in determining appropriate doses for plazomicin in indicated patients.
"Therapeutic drug monitoring aims to improve patient outcomes and reduce costs. The measurement of levels of plazomicin in blood will enable TDM-adjusted plazomicin dosing in recommended patient populations," Janet Dorling, chief commercial officer at Achaogen, said in a statement. "Monitoring plazomicin drug levels with accuracy and precision has been an important goal and, with the achievement of this regulatory milestone, we are excited about the commercialization of the QMS Plazomicin Immunoassay from Thermo Fisher."
According to the statement issued by Thermo Fisher Scientific, the immunoassays allow clinicians to monitor and administer therapies on an individual patient basis in order to optimize drug levels, and reduce the effects of under or over dosage to improve overall patient outcomes.
Plazomicin (ZEMDRI) was approved by the FDA in June as a once-daily intravenous aminoglycoside therapy for the treatment of complicated urinary tract infections (cUTIs) including acute pyelonephritis caused by certain Enterobacteriaceae including Escherichia coli, Klebsiella pneumonia, Proteus mirabilis, and Enterobacter cloacae in adult patients 18 years and older with limited or no options for alternative treatment.
The FDA’s approval was based on the results of the phase 3 clinical trial, Evaluating Plazomicin in cUTI (EPIC), in which plazomicin demonstrated noninferiority 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.