1. Pink Sheet
  2. >>Regulatory Trackers
  3. >>US FDA Performance Tracker

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.

A structurally modified cephalosporin antibacterial, cefiderocol is specifically under review for the treatment of cUTI, including pyelonephritis, due to Gram-negative bacteria

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA Performance Tracker

More from Regulatory Trackers