Achaogen Announces FDA Acceptance of New Drug Application with Priority Review for Plazomicin for Treatment of Complicated Urinary Tract Infections and Bloodstream Infections
January 02, 2018 at 01:01 pm
Share
Achaogen, Inc. announced 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. Achaogen also intends to submit an application for marketing authorization in the European Union (EU) in 2018. 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.
Achaogen, Inc. is a late-stage biopharmaceutical company. The Company is engaged in the discovery, development and commercialization of antibacterial treatments against multi-drug resistant (MDR) gram-negative infections. The Company is involved in researching and developing plazomicin, its lead product candidate, for the treatment of serious bacterial infections, including complicated urinary tract infection (cUTI), blood stream infections and other infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE). Plazomicin is an intravenous aminoglycoside antibiotic. The Company has developed plazomicin by chemically modifying sisomicin, a naturally occurring aminoglycoside, in order to overcome common aminoglycoside resistance mechanisms. The Company has a portfolio of small molecule and antibody programs. The Company's Early Development programs include C-Scape and LpxC.
Achaogen Announces FDA Acceptance of New Drug Application with Priority Review for Plazomicin for Treatment of Complicated Urinary Tract Infections and Bloodstream Infections