Achaogen, Inc. (NASDAQ: AKAO), a biopharmaceutical company discovering, developing and commercializing innovative antibacterial agents to address multi-drug resistant (MDR) gram-negative infections, today announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has provided clearance for the Thermo Scientific QMS Plazomicin Immunoassay that provides a quantitative measure of plazomicin in human plasma using automated clinical chemistry analyzers. Results of the assay will be used to assist in the management of patients receiving plazomicin therapy.
Plazomicin, marketed as ZEMDRI™ in the United States, was approved by the U.S. Food and Drug Administration for the treatment of adults with complicated urinary tract infections, including pyelonephritis, due to certain Enterobacteriaceae.
“The QMS Plazomicin Immunoassay will enable therapeutic drug management (TDM) which is critical to support the use of ZEMDRI in a subset of the more than one million annual cases of multi-drug resistant or recurrent complicated urinary tract infections in the United States,” said Janet Dorling, Achaogen’s Chief Commercial Officer. “This is an important milestone and we are excited about the commercialization of the QMS Plazomicin immunoassay.”
Thermo Fisher Scientific and Achaogen jointly developed the QMS Plazomicin immunoassay. Both companies entered into a collaboration to develop an assay that would help healthcare professionals make important dosing determinations regarding the use of ZEMDRI for appropriate patients.
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