The Food and Drug Administration (FDA) has granted Priority Review to cefiderocol (Shionogi) for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative pathogens.
The supplemental New Drug Application includes data from the phase 3 APEKS-NP (Acinetobacter baumannii, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae and Stenotrophomonas maltophilia in Nosocomial Pneumonia) trial, a double-blind, noninferiority study that evaluated the safety and efficacy of cefiderocol vs meropenem in patients with nosocomial pneumonia including HABP, VABP, and healthcare-associated bacterial pneumonia.
Patients were randomized to receive cefiderocol intravenously (IV) every 8 hours (n=145) or meropenem IV every 8 hours (n=146) for a period of 7-14 days, in addition to linezolid (to cover methicillin-resistant Staphylococcus aureus and Gram-positive bacteria). The primary efficacy outcome was all-cause mortality at day 14.
Results showed that at day 14, all-cause mortality in the modified intent-to-treat population was 12.4% for cefiderocol and 11.6% for meropenem (difference: 0.8, [95% CI, –6.6, 8.2]). As for safety, the incidence of treatment-emergent adverse events has found to be similar between the groups.
A Prescription Drug User Fee Act (PDUFA) target date of September 27, 2020 has been set for review of the application.
Cefiderocol, a novel siderophore cephalosporin, is marketed under the brand name Fetroja®. Fetroja is currently approved for the treatment of complicated urinary tract infections, including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. The treatment is indicated for patients aged ≥18 years with limited or no alternative treatment options.
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