Back to All Events

Antimicrobial Drugs Advisory Committee

On Wednesday, May 2, 2018, the Antimicrobial Drugs Advisory Committee (AMDAC) discussed a new drug application (NDA) for plazomicin, sponsored by Achaogen, Inc. (Achaogen), for the proposed indications of the treatment of complicated urinary tract infections and blood stream infections in adults.

The Committee voted unanimously (15 of 15 members) that Achaogen has provided substantial evidence of the safety and effectiveness of plazomicin for the treatment of complicated urinary tract infections (cUTI) in patients with limited or no treatment options.

However, a majority of the Committee, 11 of 15 members, voted that Achaogen has not provided substantial evidence of the safety and effectiveness of plazomicin for the treatment of bloodstream infections (BSI) in patients with limited or no treatment options.