Achaogen, Inc., a late-stage biopharmaceutical company developing antibacterials for multi-drug resistant (MDR) gram-negative infections, said that the U.S. FDA has classified the outcome of its fourth quarter 2017 re-inspection of Pfizer’s McPherson, KS facility as Voluntary Action Indicated (VAI). The company’s new drug application (NDA) for plazomicin is currently under regulatory review, and the change to VAI status provides a clear regulatory path for approval for plazomicin out of the McPherson facility based on plazomicin’s PDUFA date of June 25, 2018.   

“The upgraded VAI designation received by Pfizer’s McPherson facility is a positive outcome,” said Blake Wise, chief executive officer, Achaogen. “Our PDUFA date is five months away and, with additional clarity around our manufacturing efforts, we look forward to the potential marketing approval and launch of plazomicin.”

The company’s NDA for plazomicin is 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. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 25, 2018.