Fetroja Receives New Indication for Pneumonia

September 27, 2020 – The U.S. FDA has approved a new indication for Fetroja® (cefiderocol), manufactured by Shionogi. The drug is now indicated to treat patients 18 years of age or older diagnosed with hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible Gram- negative microorganisms.

Hospital-acquired and ventilator-associated bacterial pneumonia occur in healthcare settings when the air sacs in a patient’s lungs become inflamed due to bacterial infection. This can lead to coughing, shortness of breath, fluid buildup in the lungs, fever, and respiratory failure. Although multiple organisms can cause pneumonia, Fetroja is specifically indicated to treat pneumonia caused by Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.

In a clinical study, Fetroja was determined to be non-inferior to high dose meropenem, a current standard of care. Recommended dosing is 2g of Fetroja every eight hours, administered via intravenous infusion over the course of three hours. Dose adjustments are required for patients whose creatinine clearance (a measure of kidney health) is at least 120mL/min or less than 60 mL/min.

Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This helps to reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs.

First FDA approved in 2019, Fetroja is also indicated to treat complicated urinary tract infections.