FDA committee gives Achaogen mixed review on plazomicin
Achaogen (NASDAQ:AKAO) received a mixed review from an FDA advisory committee on its antibiotic, plazomicin, with a vote in favor of approval for complicated urinary tract infections but against its use in bloodstream infections.
"We are encouraged by the committee's unanimous vote in favor of plazomicin for complicated urinary tract infections,” CEO, Blake Wise, said in a statement.
“The discussion underscored the real-world challenges that healthcare providers face every day given limited or inadequate treatment options for certain pathogens," he added.
Regarding bloodstream infections, Mr. Wise said the Limited-Population Antibacterial Drug pathway, or LPAD, is a novel approach that enables the FDA to consider the “benefits and risks for the sickest patients who have few or no available treatment options, and to approve antibiotics like plazomicin that we believe, have the potential to address these limited patient populations.”
The FDA is not bound by the committee's votes but takes its input into consideration when reviewing marketing applications. Plazomicin has a PDUFA date of June 25. If the FDA approves plazomicin by the target action date, Achaogen expects to launch plazomicin in the U.S. soon afterwards.