The ID Pipeline: FDA Activity From the Week of November 10, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of November 10, 2019.

Cefiderocol Approved by FDA for cUTI

On Thursday, November 14, 2019, the FDA approved cefiderocol (Fetroja) for the treatment of complicated urinary tract infections (cUTI), including kidney infections caused by susceptible gram-negative microorganisms in adults, who have limited or no alternative treatment options. The approval was granted to Shionogi Inc.

Cefiderocol is a siderophore cephalosporin. It is active against all classes of β-lactamases, which enables it to overcome the primary mechanisms of gram-negative bacterial resistance to β-lactam antibiotics.

The safety and effectiveness of cefiderocol was demonstrated in a study of 448 patients with cUTIs. In the study, 72.6% of patients who received cefiderocol had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared to 54.6% of patients who received an alternative antibiotic. The clinical response rates were similar between the treatment groups.

The full article is available here.