The US Food and Drug Administration (FDA) has approved a new antibiotic for patients with severe urinary tract infections and few other treatment options.
The agency announced late yesterday that is has approved cefiderocol for the treatment of complicated urinary tract infections (cUTIs), including kidney infections, caused by gram-negative bacteria in patients with limited or no other treatment options. FDA approval was based on the results of a multinational randomized phase 2 clinical trial that evaluated the safety and efficacy of the drug in patients with cUTI versus a comparator antibiotic (imipenem-cilastatin).
The results of the trial showed that symptoms were resolved and bacteria eradicated 7 days after treatment in 72.6% of patients (183 of 252) administered cefiderocol, compared with 54.6% of patients (65 of 119) in the imipenem-cilastatin arm. Clinical response rates (resolution of symptoms alone) were similar between the two groups.
Novel mechanism of action
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