The US Food and Drug Administration (FDA) on Thursday authorised the marketing of the antibacterial drug Fetroja (cefiderocol) for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI) under its Qualified Infectious Disease Product (QIDP) designation's priority review.

This approval was awarded to Shionogi & Co Ltd.

Under ongoing efforts to address antimicrobial resistance, the agency approved Fetroja for treatment of patients 18 years of age or older with cUTI, including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options.

The safety and effectiveness of Fetroja was demonstrated in a study of 448 patients with cUTI. Of the patients administered with Fetroja, 72.6% had resolution of symptoms and eradication of the bacteria seven days after completing treatment, versus 54.6% in patients who received an alternative antibiotic. The clinical response rates were similar in two treatment groups.