Achaogen Inc (NASDAQ:AKAO) has announced that its New Drug Application (NDA) for plazomicin has received an upgraded status from the Food and Drug Administration (FDA).
Achaogen deals with late-stage innovative antibacterials designed to dress multi-drug resistant (MDR) infections. The company revealed that the FDA has classified the results of the re-inspection of the McPherson facility which belongs to Pfizer Inc. (NYSE: PFE). The results were classified as a Voluntary Action Indicated (VAI). The VAI regulatory status sets a clear path for the approval of Chaogen’s new NDA for plazomicin from the McPherson facility based on the PDUFA date on June 25 this year as set by the FDA.
“The upgraded VAI designation received by Pfizer’s McPherson facility is a positive outcome. 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,” stated Achaogen CEO, Blake Wise.
Achaogen filed the plazomicin NDA so that the drug can be approved for treating complex urinary tract infections such as pyelonephritis. It will also be used to treat bloodstream infections caused by Enterobacteriaceae especially in patients who do not have other treatment alternatives.
Earlier this month, Achaogen announced that the FDA had accepted the NDA for Plazomicin as a treatment option for UTIs. The company also revealed that the NDA had been granted priority review which was expected to speed up the review process. The announcement about the FDA’s acceptance of the NDA had a positive impact on the company’s stock and the same was observed yesterday when shares rallied after the announcement of the upgraded status.
Achaogen submitted the NDA for Plazomicin with data collected from two phase 3 studies which were given the names EPIC and CARE. The two clinical studies evaluated patients that suffered from serious infections that resulted from gram-negative bacteria that are resistant to treatment using multiple antibiotics. The data obtained from the two clinical studies demonstrated significant progress in the health of the patients.
Achaogen stock closed the latest trading session on Tuesday at $12.17 after a 10.04 percent gain compared to the value of the stock during the previous close.