Priority Review Granted for Treatment of Complicated UTI, Bloodstream Infections
Plazomicin was also granted Breakthrough Therapy designation for the treatment of bloodstream infections caused by certain Enterobacteriaceae.
A New Drug Application (NDA) for plazomicin – an investigational treatment for complicated urinary tract infections (cUTI), including pyelonephritis, and bloodstream infections (BSI) – has been accepted and also granted Priority Review by the Food and Drug Administration (FDA).
Plazomicin was developed to treat serious bacterial infections due to multi-drug resistant (MDR) Enterobacteriaceae. A Phase 3 trial (EPIC) which included 609 patients with cUTI and acute pyelonephritis found plazomicin to be non-inferior to meropenem.
The NDA is supported by data from EPIC and also data from the CARE clinical trial, which found that patients with serious infections due to carbapenem-resistant Enterobacteriaceae had a lower rate of mortality when treated with plazomicin compared to colistin therapy.
A Prescription Drug User Fee Act (PDUFA) target action date of June 25, 2018 has been set by the FDA. “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," said Blake Wise, Achaogen's CEO.
Plazomicin has also been granted Breakthrough Therapy designation for the treatment of bloodstream infections caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options.
Achaogen announces FDA acceptance of new drug application with priority review for plazomicin for treatment of complicated urinary tract infections and bloodstream infections [press release]. San Francisco, California: Achaogen. Published January 2, 2018. Accessed January 9, 2018.