Shionogi said the FDA has accepted its supplemental New Drug Application for Fetroja (cefiderocol) to treat pediatric patients, from at least 26 weeks of gestational age up to 18 years, with hospital‑acquired and ventilator‑associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram‑negative bacteria.
The agency has set a Prescription Drug User Fee Act target action date of February 23, 2027. The submission is supported by three clinical studies that evaluated safety, tolerability, pharmacokinetics, and efficacy in 154 children within the specified age range with cUTI, HABP/VABP and other infections due to suspected or confirmed Gram‑negative pathogens.
Cefiderocol, a siderophore cephalosporin, is already approved in the United States for adult patients with cUTI and HABP/VABP caused by certain Gram‑negative organisms. Extending its label to pediatric use is intended to address a treatment gap for younger patients facing drug‑resistant infections.
In 2023, cefiderocol was included on the World Health Organization’s Paediatric Drug Optimization priority list, which highlights medicines urgently needed for children where dosing, safety data, or age‑appropriate formulations are limited.
Shionogi noted that the planned pediatric HABP/VABP expansion is supported by an ongoing U.S. government contract under BARDA’s Project BioShield, aimed at strengthening national preparedness for drug‑resistant bacterial threats.
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