US FDA approves first siderophore antibiotic, cefiderocol (Fetroja)


The US FDA has approved cefiderocol (Fetroja), a siderophore cephalosporin that inhibits bacterial cell wall synthesis by binding penicillin binding protein 3 and uses the siderophore to bind free iron and gain additional cell entry. Fetroja is the first approved antibiotic that functions as a siderophore.

The approval is for the treatment of complicated urinary tract infections (cUTIs) in patients over 18 years old with limited or no alternative treatment options. The approval follows results from the PEKS-cUTI trial that enrolled 4448 patients with cUTIs. Of the patients receiving Fetroja, 72.6% had a resolution of symptoms and eradication of the bacteria compared with 54.6% of patients receiving imipenem–cilastatin. The clinical response rate was similar between both treatment groups.

However, the labelling for Fetroja does contain a warning regarding the higher all-cause mortality rate observed in Fetroja-treated patients compared with other antibiotics in a trial of critically ill patients with multidrug-resistant Gram-negative infections – the cause of this disparity has not been established.

The approval is granted to Shionogi & Co (Osaka, Japan).

John Farley, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, commented: “Today’s approval provides an additional treatment option for patients with cUTIs who have limited or no alternative treatment options. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections.”

Paula Garvey, Manship Chair of Medicine at the Louisiana State University School of Medicine (LA, USA), concluded: “With today’s approval of cefiderocol, the infectious disease community now has a new type of antibiotic with a unique mechanism of cell entry to add to their toolkit to assist in the complexity of treating highly resistant pathogens that are occurring with increasing frequency in life-threatening infections.”

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