FDA Accepts Shionogi’s sNDA for Fetroja® (cefiderocol) for Use in Pediatric Patients with Serious Infections Caused by Susceptible Gram-negative Bacteria

Submission intends to address a critical therapeutic gap for vulnerable young patients facing drug-resistant pathogens

FLORHAM PARK, N.J., July 16, 2026--(BUSINESS WIRE)--Shionogi Inc., a New Jersey-based subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter "Shionogi") announced the U.S. Food and Drug Administration (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 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.1,2,3

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.4

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 certain susceptible Gram-negative bacterial infections.5 For full Prescribing Information for Fetroja, including approved indications and Safety Information, please visit https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf.

About Shionogi in Infectious Disease
Over the past 70 years, Shionogi has discovered and commercialized six novel antibiotics. Today, our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Our global pipeline includes investigational agents to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus.