High-priority and challenging pathogens (US isolates) are highly susceptible to Fetroja in vitro1

In vitro activity does not necessarily correlate with clinical efficacy

Fetroja in vitro susceptibility using FDA-approved breakpointsa
99%
(n=10,186)
Enterobacteriaceae
overall
91%
(n=162)
Enterobacteriaceae
carbapenem non-susceptible
98%
(n=2445)
P aeruginosa
overall
97%
(n=468)
P aeruginosa
carbapenem non-susceptible
Fetroja in vitro susceptibility using CLSI investigational breakpointsb
98%
(n=1049)
A baumannii
overall
96%
(n=548)
A baumannii
carbapenem non-susceptible
99%
(n=596)
S maltophilia
overall
(inherently carbapenem-resistant)2,3
Fetroja has no clinically relevant in vitro activity against most Gram-positive bacteria or anaerobic bacteria4
a FDA breakpoints used for Enterobacteriaceae MIC ≤2 μg/mL and P aeruginosa MIC ≤1 μg/mL.
b CLSI investigational breakpoint used for A baumannii and S maltophilia MIC ≤4 μg/mL.

In vitro susceptibility study design1

Clinical isolates of Gram-negative bacteria were collected in the United States from 2014-2018 for one study that included Enterobacteriaceae* and non-fermenter strains. The Proteeae study isolates were collected from 2013-2016 and were tested centrally (IHMA Inc., Schaumburg, IL, USA). Fetroja MICs were determined by microbroth dilution using iron-depleted cation-adjusted Mueller-Hinton broth (ID-CAMHB) as approved by the Clinical and Laboratory Standards Institute (CLSI) subcommittee on antimicrobial susceptibility testing in January 2016. FDA breakpoints were used for Enterobacteriaceae MIC ≤2 μg/mL and P aeruginosa MIC ≤1 μg/mL, whereas CLSI investigational breakpoint was used for A baumannii and S maltophilia MIC ≤4 μg/mL. Carbapenem non-susceptible strain was defined as meropenem MIC ≥2 μg/mL for Enterobacteriaceae (including Proteeae) strains and MIC ≥4 μg/mL for P aeruginosa and A baumannii.

* E coli, K pneumoniae, other Klebsiella spp, Enterobacter spp, Serratia spp, and Citrobacter spp.
Morganella morganii, Proteus mirabilis, Proteus vulgaris, and Providencia rettgeri

Even carbapenem non-susceptible pathogens remain susceptible to Fetroja in vitro1