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BioWorld - Sunday, April 26, 2026
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Home » Plazomicin gets split decision on LPAD path to first approval
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Plazomicin gets split decision on LPAD path to first approval

May 3, 2018
By Marie Powers
As the tenor of presentations by officials from Achaogen Inc. and the FDA at Wednesday's Antimicrobial Drugs Advisory Committee (AMDAC) meeting seemed to suggest, the new drug application (NDA) for plazomicin received a ringing 15-0 endorsement in passing the safety and efficacy bar to treat complicated urinary tract infections (cUTIs) caused by multidrug-resistant pathogens, including Escherichia coli, Klebsiella pneumoniae, Proteus spp and Enterobacter cloacae. However, with 11 opposed and four in favor (one committee member left early and did not vote on either question), the aminoglycoside antibacterial candidate drew a strong thumb's down for the treatment of bloodstream infections (BSIs) caused by K. pneumoniae and E. coli.
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