Achaogen, Inc., a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, announced this week that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for plazomicin for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and bloodstream infections (BSI) due to certain Enterobacteriaceae in patients who have limited or no alternative treatment options. FDA has granted the NDA Priority Review and set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 25, 2018.
“The number of confirmed cases of CRE annually in the U.S. is at least 70,000, and is projected to double by 2022,” said Blake Wise, Achaogen’s Chief Executive Officer. “We are excited about plazomicin’s potential to address certain multi-drug resistant gram-negative infections and feel that plazomicin would be a valuable new treatment option for patients with serious bacterial infections, including those due to CRE and ESBL-producing Enterobacteriaceae.”
Plazomicin was developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including extended spectrum beta-lactamase (ESBL) producing and carbapenem-resistant Enterobacteriaceae (CRE), and has been evaluated in two Phase 3 clinical trials, EPIC and CARE.
In its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application. The NDA is supported by data from both the EPIC and CARE clinical trials which evaluated the safety and efficacy of plazomicin in patients with serious infections caused by gram-negative pathogens, including extended-spectrum beta-lactamase (ESBL) producing and carbapenem-resistant Enterobacteriaceae (CRE). The FDA granted Breakthrough Therapy designation for plazomicin for the treatment of bloodstream infections (BSI) caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that target serious or life-threatening conditions. Plazomicin has also received Qualified Infectious Disease Product (QIDP) designation from the FDA which provides incentives for the development of new antibiotics, including priority review and an additional five years of market exclusivity.
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