1 June 2020 - - The US Food and Drug Administration has accepted Japan-based Shionogi and Co's supplemental New Drug Application for Fetroja (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020, the company said.

Shionogi submitted the sNDA for Fetroja for the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible Gram-negative pathogens.

HABP and VABP are also sometimes referred to as nosocomial pneumonia.

The sNDA is based on results from 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).

The FDA approved Fetroja in November 2019 for patients 18 years of age or older who have limited or no alternative treatment options, 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.

APEKS-NP (Acinetobacter baumannii, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae and Stenotrophomonas maltophilia in Nosocomial Pneumonia) was a multinational, multicenter, double-blind, randomised, non-inferiority trial designed to evaluate the efficacy and safety of Fetroja for the treatment of nosocomial pneumonia including HABP, VABP, and HCABP caused by Gram-negative pathogens.

Patients were randomized on a 1: 1 basis to receive Fetroja administered by intravenous infusion of two grams over a three-hour period every eight hours or high-dose (two grams) extended-infusion (over three-hours) meropenem administered every eight hours, for seven to 14 days in the hospital.

Linezolid was additionally administered for at least five days in both arms to provide coverage for methicillin-resistant Staphylococcus aureus (MRSA) and for Gram-positive bacteria, in the Fetroja group.

Safety was investigated up to 28 days after the end of treatment unless there was an ongoing serious adverse event(s).