Achaogen Inc.’s (AKAO) Plazomicin, which won the FDA panel backing for one of the two proposed indications early this month, now awaits the final decision on June 25, 2018.
The Company is seeking approval of Plazomicin for the treatment of adults with complicated urinary tract infections, including pyelonephritis, and for the treatment of bloodstream infections (BSI) due to certain Enterobacteriaceae in patients who have limited or no alternative treatment option.
On May 2, 2018, the panel backed Plazomicin for the treatment of complicated urinary tract infections, including pyelonephritis, and was not in favor for the treatment of bloodstream infections (BSI) in adults with limited or no treatment options.
The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.
If approved, Plazomicin could contribute $313 million in peak sales by 2022, according to market research firm EvaluatePharma.
AKAO closed Friday’s (May 25) trading at $12.17, up 3.75%.