Shionogi has secured approval from the US Food and Drug Administration (FDA) for its Fetroja (cefiderocol) to treat complicated urinary tract infections (cUTI) in adult patients with limited or no alternative treatment.
Fetroja has been approved for patients 18 years of age or older who have limited or no alternative treatment options to treat cUTI, including pyelonephritis.
It can be used to treat cUT caused by susceptible Gram-negative microorganisms such as Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex.
The approval of Fetroja was based on data from the APEKS-cUTI study, which is a multinational, multicentre and double-blind clinical trial designed to assess the efficacy and safety of Fetroja against imipenem/cilastatin (IPM/CS) in patients with cUTI.
According to the company, the trial results demonstrated the response rates for the composite endpoint of microbiological eradication and clinical response at the test of cure (TOC) were significantly higher in the FETROJA arm compared to the IPM/CS arm.
Fetroja is a cephalosporin antibiotic that includes a novel mechanism to penetrate the outer cell membrane of Gram-negative pathogens by acting as a siderophore.
Fetroja, which binds to ferric iron, will be actively transported into bacterial cells through the outer membrane via the bacterial iron transporters that will help provide essential nutrient for bacteria.
The mechanisms will enable cefiderocol to achieve higher concentrations in the periplasmic space where it can bind to penicillin-binding proteins and restrict cell wall synthesis in the bacterial cells.
Shionogi president and CEO Dr Isao Teshirogi said: “FETROJA will fill a very important unmet medical need because of its unique method of penetrating the cell wall of Gram-negative bacteria and its ability to overcome many of the resistance mechanisms that bacteria employ against antibiotics.
“Today’s approval represents Shionogi’s ongoing commitment to develop medicines that help fight these life-threatening infections in patients for whom limited or no alternative treatment options exist.”
In October, GlaxoSmithKline (GSK) has launched a phase 3 clinical programme to evaluate its antibiotic candidate gepotidacin for the treatment of uncomplicated urinary tract infection (uUTI) and urogenital gonorrhoea (GC).