Concerns over disproportionate mortality had not stopped a panel of experts to recommend that the FDA approve Shionogi’s antibiotic cefiderocol for complicated urinary tract infections, raising hopes of an OK next month.
After discussing the imbalance in deaths between the cefiderocol and control arms flagged by the agency’s in-house review, the majority of the Antimicrobial Drugs Advisory Committee voted in favor of the drug. More specifically, 14 agreed that there’s substantial evidence of efficacy and safety for cefiderocol in treating cUTI, while two voted against.
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