The US FDA has approved cefiderocol (Fetroja), a new antibiotic developed by Shionogi & Co, for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI).
The safety and effectiveness of cefiderocol was demonstrated in a study of 448 patients with cUTIs. Of the patients who were administered cefiderocol, 72.6% had resolution of symptoms and eradication of the bacteria approximately seven days after completing treatment, compared with 54.6% in patients who received an alternative antibiotic. The clinical response rates were similar between the two treatment groups.
Labelling for cefiderocol includes a warning regarding the higher all-cause mortality rate observed in cefiderocol-treated patients compared to those treated with other antibiotics in a trial in critically ill patients with multidrug-resistant Gram-negative bacterial infections.
The cause of the increase in mortality has not been established. Some of the deaths were a result of worsening or complications of infection or underlying co-morbidities.
Cefiderocol received the FDA’s Qualified Infectious Disease Product (QIDP) designation.