Antimicrobial Committee Supports NDA for Treating Complicated UTIs

October 25, 2019

The FDA’s Antimicrobial Drugs Advisory Committee voted 14-2 to support Shionogi’s NDA for cefiderocol lyophilized powder for IV administration to treat complicated urinary tract infection (cUTI). 

The expert committee decided that Shionogi’s safety and efficacy data supported the proposed indication of treating cUTI including kidney infection in patients with limited or no alternative treatment options.

Although a majority of the panel voted in favor of the drug for the indication, some committee members were concerned about off-label use and noted the clinical data showed higher mortality in critically-ill patients treated with cefiderocol.

View today's stories