Shionogi’s Antibacterial Drug Gets FDA Approval for Treating Complicated UTIs

The FDA approved Shionogi’s Fetroja (cefiderocol) to treat complicated urinary tract infections (cUTI) caused by susceptible Gram-negative microorganisms, in patients 18 and older who have limited or no alternative treatment options.

The approval was based on a study of 448 patients with cUTIs. Of the patients treated with Fetroja, 72.6 percent saw their symptoms resolved and the bacteria eradicated approximately seven days after finishing treatment, compared with 55 percent of patients who received an alternative antibiotic.

Fetroja received a fast track designation and a priority review.