Shionogi's antibiotic Fetroja garners FDA approval for complicated urinary tract infections

Shionogi announced that the FDA approved Fetroja (cefiderocol) for use in patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options. The company indicated that the siderophore cephalosporin antibiotic is expected to become commercially available in early 2020.

"A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs," remarked John Farley, acting director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research. Farley added that the approval of Fetroja "represents another step forward in the FDA's overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections."

Approval of Fetroja comes after an FDA advisory committee voted 14 to 2 in favour of the drug last month. The regulator noted that the efficacy of Fetroja was demonstrated in the APEKs-cUTI study of 448 patients with cUTIs, with results showing that 72.6% of those who received the drug had resolution of symptoms and eradication of the bacteria approximately seven days after completing treatment, compared with 54.6% in subjects who received an alternative antibiotic. Data indicated that the clinical response rates were similar between the two treatment groups.

The FDA said that Fetroja's label includes a warning regarding the higher all-cause mortality rate observed in patients given the drug compared to those treated with other antibiotics in a trial in critically ill patients with multidrug-resistant Gram-negative bacterial infections, including hospital-acquired/ventilator-associated pneumonia, bloodstream infections or sepsis. The agency noted that the cause of the increase in mortality has not been established, although some of the deaths were a result of worsening or complications of infection, or underlying co-morbidities.

Earlier this year, the European Medicines Agency accepted a marketing application for cefiderocol for the treatment of infections due to aerobic Gram-negative bacteria in adults with limited treatment options, with the agency granting the filing accelerated assessment.

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