It bypasses the bacterial porin channels by using the bacterias own iron-transport system for being transported in. History
Cefiderocol received a Qualified Infectious Disease Product designation from the U.S. Food and Drug Administration (FDA) and was granted priority review. In November 2019, the FDA granted approval of cefiderocol to Shionogi & Co. as an antibacterial drug for treatment of adults 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 safety and effectiveness of cefiderocol was demonstrated in a study (NCT02321800) of 448 participants with cUTIs. Of the participants who were administered cefiderocol, 72.6% had resolution of symptoms and eradication of the bacteria approximately seven days after completing treatment, compared with 54.6% in participants who received an alternative antibiotic. The clinical response rates were similar between the two treatment groups. The trial included participants from Europe, United States and Mexico.In the clinical trial, participants with cUTI were chosen at random to receive cefiderocol, or another antibacterial drug called imipenem/cilastatin. Both treatments were given intravenously for 7–14 days and neither the participants nor the health care professionals knew which drugs were given until after the trial was complete.
Participants could not be switched to an oral antibacterial drug to complete the treatment for cUTI.The benefit of cefiderocol was measured by the proportion of participants who achieved cure or improvement in their symptoms related to cUTI and a negative urine culture test in comparison to imipenem/cilastatin.In April 2020, Cefiderocol was approved for medical use in the European Union . References
Further reading
Committee for Medicinal Products for Human Use (27 February 2020). "Fetcroja : EPAR - Public assessment report" (PDF). European Medicines Agency (EMA). EMA/136096/2020. External links
"Cefiderocol". Drug Information Portal. U.S. National Library of Medicine. "Cefiderocol sulfate tosylate". Drug Information Portal. U.S. National Library of Medicine. Clinical trial number NCT02321800 for "A Study of Efficacy and Safety of Intravenous Cefiderocol (S-649266) Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections (APEKS-cUTI)" at ClinicalTrials.gov