Shionogi & Co., Ltd. Monday announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for FETROJA ® (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coliEnterobacter cloacae complex, Klebsiella pneumoniaePseudomonas aeruginosa and Serratia marcescens.

carbapenem-resistant Klebsiella pneumoniae (CRKP) /CDC

“Antimicrobial resistance is a major global health concern, and there is a clear need for new treatments such as FETROJA to give clinicians more options to fight life-threatening infections caused by Gram-negative pathogens,” said Akira Kato, Ph.D., president and CEO at Shionogi Inc. “This milestone represents Shionogi’s long-standing and unwavering commitment to constantly fight evolving infectious diseases in an era realizing significant unmet needs.”

This expanded indication is based on the results of the Phase III 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 study drug in the treatment of patients with HABP, VABP and healthcare-associated bacterial pneumonia (HCABP).

“Nosocomial pneumonia is one of the most common hospital-acquired infections and a rising number are caused by difficult-to-treat, multidrug-resistant pathogens, which can be a deadly threat for patients,” said APEKS-NP principal investigator Richard G. Wunderink, M.D., Northwestern University Feinberg School of Medicine. “The results from the APEKS-NP study show that cefiderocol is a much-needed additional option for the treatment of patients with HABP and VABP due to multidrug-resistant Gram-negative bacteria.”

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FETROJA is currently approved for patients 18 years of age or older for the treatment of complicated urinary tract infections, including pyelonephritis, caused by Gram-negative pathogens. It is the first approved antibiotic that functions as a siderophore and has a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens including carbapenem-resistant strains.