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Possible Mortality Imbalance For Shionogi's Cefiderocol On US FDA Panel Agenda

 
• By Michael Cipriano

Although cefiderocol demonstrated safety and efficacy in a pivotal trial for complicated urinary tract infections, there was a mortality imbalance between the study drug and comparator arms in a separate descriptive trial; the US FDA is unsure whether the imbalance was a "chance finding."

X-ray image of bladder, Showing cystitis or lower urinary tract infection
Shionogi's cUTI Candidate Cefiderocol Will Head To A US FDA Advisory Committee.

The US Food and Drug Administration will convene its Antimicrobial Drugs Advisory Committee 16 October to assess whether a mortality imbalance in a descriptive clinical trial for Shionogi & Co. Ltd.'s structurally modified cephalosporin antibacterial cefiderocol is reflective of the drug's activity or a "chance" finding.

Shionogi is specifically seeking an indication for the intravenous cefiderocol to treat complicated urinary tract infections (cUTI), including pyelonephritis due to Gram-negative

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