Japanese drug developer, Shionogi, announced that its antibiotic, Fetroja (cefiderocol), received approval by the US Food and Drug Administration (FDA) for the treatment of patients of 18 years or older with complicated urinary tract infections (cUTIs), including pyelonephritis, who have limited or no alternative treatment options.
The director of the Office of Infectious Diseases, part of the FDA’s Center for Drug Evaluation and Research, John Farley, commented that the approval is part of the agency’s effort to fight antimicrobial resistance (AMR), which forms a ‘key global challenge’.
Instances of cUTIs are caused by susceptible Gram-negative bacteria, including escherichia coli, klebsiella pneumoniae, proteus mirabilis, pseudomonas aeruginosa, and enterobacter cloacae complex.
Fetroja’s mechanism of action enables the drug to penetrate the cell walls of the previously mentioned bacteria, overcoming many of the resistance mechanisms that they employ against antibiotics, Isao Teshirogi, the company’s CEO, explained.
The approval of Fetroja by the FDA came after clinical studies wherein 72.6% out of 448 patients with cUTIs had resolution of symptoms and eradication of the bacteria, compared to 54.6% in patients who received an alternative antibiotic.
The drug product received a qualified infectious disease product designation by the FDA, as well as a priority review designation.
Shionogi stated that the increasing antibiotic resistance of infections caused by Gram-negative bacteria poses a ‘serious health challenge’, resulting in high mortality rates.
More specifically, more than 2.8 million antibiotic-resistant infections occur each year in the US, causing the death of over 35,000 patients, while approximately 25,000 people die from an infection by multidrug-resistant bacteria every year in the European Union.
Fetroja’s approval comes shortly after GSK announced the initiation of Phase III clinical trials for its antibiotic, gepotidacin, as a potential treatment for urinary tract infection.