Positive advisory committee decision for Plazomicin for treatment of adults with complicated urinary tract infections.-Achaogen, Inc.
Achaogen, Inc. has announced that the FDA Antimicrobial Drugs Advisory Committee voted on the two points for Advisory Committee consideration in relation to Plazomicin for treatment of adults with complicated urinary tract infections ,as follows: 1. Has the applicant provided substantial evidence of the safety and effectiveness of plazomicin for the treatment of complicated urinary tract infections? Result: (15-0-0) There were 15 yes votes and zero no votes. No members of the panel abstained. 2. Has the applicant provided substantial evidence of the safety and effectiveness of plazomicin for the treatment of bloodstream infections in patients with limited or no treatment options? Result: (4-11-0) There were four yes votes and 11 no votes. No members of the panel abstained.
There were 16 panel members at the meeting, one of whom departed prior to the vote and was therefore not present for the voting. The FDA is not bound by the Committee's votes but takes its input into consideration when reviewing marketing applications. Plazomicin has a Prescription Drug User Fee Act (PDUFA) date of June 25, 2018. If the FDA approves plazomicin by this target action date, Achaogen expects to launch plazomicin in the U.S. soon thereafter.
Comment: The FDA advisory committee meeting on antibiotic plazomicin is seen as "mixed" with a vote in favor of approval for complicated urinary tract infections but against its use in bloodstream infections.
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