Antibacterial drug Fetroja (cefiderocol) has been approved to treat patients aged 18 years and older with complicated urinary tract infections (cUTIs), the U.S. Food and Drug Administration announced yesterday.

The drug is indicated for patients with limited or no alternative treatment options for cUTI, including kidney infections caused by susceptible Gram-negative microorganisms. Dosage is 2 g of Fetroja every eight hours administered by intravenous infusion over three hours. Dose adjustments are required based on creatinine clearance. Prescription labeling on Fetroja includes a warning for a higher all-cause mortality rate in Fetroja-treated critically ill patients with multidrug-resistant Gram-negative bacterial infections.

Approval of Fetroja was based on safety and efficacy data from 448 patients with cUTI in the APEKS-cUTI study. Symptoms resolved and bacteria were eradicated in 72.6 percent of patients who received Fetroja seven days after treatment completion versus 54.6 percent of patients who received imipenem/cilastatin. Clinical response rates were similar between the two groups of patients.

The cause of the higher mortality rate with Fetroja in critically ill patients with multidrug-resistant Gram-negative bacterial infections is unknown. According to the FDA, some of the deaths were due to worsening or complications of infection or underlying comorbidities. This higher mortality rate was also seen among patients treated for hospital-acquired/ventilator-associated pneumonia, bloodstream infections, or sepsis. The agency noted that the safety and efficacy of Fetroja for treating these types of infections has not been determined.

The most commonly reported adverse reactions with Fetroja included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion site reactions, candidiasis, cough, headache, and hypokalemia. Patients who have had severe hypersensitivity to beta-lactam antibacterial drugs should not take Fetroja.

Approval was granted to Shionogi & Co.

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