Cefiderocol in Urinary Tract Infections
But boxed warning needed, along with more data on uses for other hard-to-treat infections
SILVER SPRING, Md. -- An FDA advisory panel voted 14-2 to recommend approval for cefiderocol, a novel antibiotic for complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no other treatment options.
While members of the FDA's Antimicrobial Drugs Advisory Committee were mostly impressed by the data submitted for the drug, they raised concern about a mortality imbalance disfavoring cefiderocol in the CREDIBLE-CR study, which compared the drug to best available therapy in patients with a variety of carbapenem-resistant infections.
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