Priority Review for Achaogen's plazomicin

FDA accepted and granted Priority Review to an NDA from Achaogen Inc. (NASDAQ:AKAO) for plazomicin (formerly ACHN-490) to treat complicated urinary tract infections (cUTIs), including pyelonephritis, and bloodstream infections due to Enterobacteriaceae in patients with limited or no alternative treatment options. The PDUFA date is June 25.

Achaogen expects an FDA advisory committee to discuss the NDA. CEO Blake Wise told BioCentury the company also plans to submit an MAA to EMA later this year seeking approval for the same indications...