The US FDA has accepted a supplemental New Drug Application (sNDA) for Fetroja (cefiderocol, Shionogi & Co Ltd) and granted the drug a Priority Review designation. Fetroja is intended to treat adult patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative pathogens.
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).
“We are committed to working with the FDA in order to bring Fetroja to more patients fighting these challenging and life-threatening Gram-negative infections as quickly as possible,” said Akira Kato, PhD, president and CEO at Shionogi Inc. “This submission represents our heritage in and commitment to developing antimicrobial therapies and filling unmet needs in the field of infectious disease.”
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.
Fetroja (cefiderocol) is a cephalosporin antibiotic with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore. In addition to entering cells by passive diffusion through porin channels, Fetroja binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria.These mechanisms allow Fetroja to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells.