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Cefiderocol Approval Likely After Panel Vote, But Future Still Clouded

 
• By Michael Cipriano

Shionogi's cUTI drug clears US FDA advisory committee by 14-2, though a black box warning is possible after one of the clinical studies showed a potential mortality imbalance disfavoring cefiderocol in other diseases.

FDA Advisory Committee Feature image

Shionogi & Co. Ltd.'s cefiderocol is likely headed for approval for a complicated urinary tract infections (cUTI) indication following a 14-2 endorsement from the US Food and Drug Administration's Antimicrobial Drugs Advisory Committee on 16 October, although the company will also have to study a potential mortality imbalance further as it pursues other indications.

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