Posted by Michael Wonder on 29 Sep 2020
Shionogi announces FDA approval of Fetroja (cefiderocol) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
29 September 2020 - Shionogi today announces that the U.S. FDA has approved a supplemental new drug application for Fetroja (cefiderocol) for the treatment of 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.
This expanded indication is based on the results of the Phase 3 APEKS-NP trial, 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 study drug in the treatment of patients with hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and health care-associated bacterial pneumonia.
