Shionogi antibiotic overcomes mortality concerns to win FDA panel’s support

Shionogi & Co. Ltd. (Tokyo:4507) said FDA’s Antimicrobial Drugs Advisory Committee on Wednesday recommended approving Fetroja cefiderocol to treat complicated urinary tract infections including pyelonephritis caused by Gram-negative bacteria in patients with limited or no alternatives. The committee voted 14-2 that Shionogi demonstrated efficacy and provided “sufficient” evidence of safety.

The PDUFA date for the siderophore cephalosporin antibiotic is Nov. 14...