FDA panel votes 14-2 to recommend approval of cefiderocol for cUTI

The US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee yesterday voted to recommend approval of the investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options.

The Advisory Committee voted 14 to 2 that the drug’s developer, Shionogi (TYO: 4507), provided substantial evidence about the efficacy and sufficient evidence of the safety of cefiderocol as part of its New Drug Application (NDA). Cefiderocol is also under review with the European Medicines Agency.

If approved, cefiderocol will be marketed under the brand name Fetroja, the Japanese pharma major noted.