FDA plans Advisory Committee Meeting for plazomicin for the treatment of complicated urinary tract infections .- Achaogen, Inc.

Achaogen, Inc. a late-stage biopharmaceutical company developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, announced that the Antimicrobial Drugs Advisory Committee of the FDA has planned a meeting to 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 option.In the NDA acceptance letter, the FDA stated that it was planning to hold an advisory committee meeting and the Company has announced that the meeting is planned to take place on 2 May 2018.

The target action date under thePrescription Drug User Fee Act (PDUFA) is 25 June 2018.