FDA panel hits Achaogen’s Plazomicin UTI treatments

Achaogen announced that the U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee voted on the two points for Advisory Committee consideration 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.

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