FDA Accepts Fetroja sNDA for Pediatric HABP/VABP and Complicated Urinary Tract Infections – Shionogi

Shionogi & Co announced the FDA has accepted a Supplemental New Drug Application (sNDA) for Fetroja (cefiderocol) for the treatment of pediatric patients (at least 26 weeks of gestational age) with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Gram-negative microorganisms.

The FDA has set an action date of February 23, 2027 under the Prescription Drug User Fee Act (PDUFA). The sNDA was submitted by Shionogi Inc., the U.S. subsidiary of Shionogi & Co., Ltd., and is supported by results from three clinical studies that investigated the safety, tolerability, pharmacokinetics and efficacy of cefiderocol in 154 children from birth (at least 26 weeks of gestational age) to less than 18 years of age, with cUTI, HABP/VABP and other infections caused by suspected or confirmed Gram-negative bacteria.

In 2023, cefiderocol was included in the World Health Organization’s PAediatric Drug Optimization (PADO) priority list, which identifies medicines most urgently needed for children, especially where there are gaps in dosing, safety data, or age-appropriate formulations.

The expansion of Fetroja for pediatric HABP/VABP is supported by an ongoing contract with the U.S. Government through the Biomedical Advanced Research and Development Authority’s (BARDA) Project BioShield. This project has been funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50126C00004.

Fetroja is approved in the U.S. for the treatment of adult patients with cUTIs, including pyelonephritis and HABP/VABP caused by suspected or confirmed Gram-negative bacterial infections