Shionogi Expanded Use for Fetroja

FDA has approved a Shionogi & Co. supplemental NDA for Fetroja (cefiderocol) for treating patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens. The expanded indication is based on the results from the Phase 3 APEKS-NP study, which showed Fetroja met the primary endpoint of non-inferiority compared to high-dose extended-infusion meropenem in all-cause mortality 14 days after initiation of the study drug in the target population, the company says. Fetroja is currently approved for patients 18 years of age or older for treating complicated urinary tract infections, including pyelonephritis, caused by Gram-negative pathogens.