FDA Accepts Shionogi's sNDA for Fetroja (Cefiderocol) in Pediatric Patients with Serious Gram-Negative Infections
核心洞察
The FDA has accepted Shionogi (搜索)'s supplemental New Drug Application for Fetroja (cefiderocol) for pediatric patients with HABP/VABP and cUTI, setting a PDUFA action date of February 23, 2027.
The sNDA is supported by three clinical studies evaluating safety, tolerability, pharmacokinetics, and efficacy in 154 children from birth to under 18 years of age.
Cefiderocol was included in the WHO's 2023 PAediatric Drug Optimization (PADO) priority list, highlighting the urgent need for pediatric antibiotics against drug-resistant pathogens.
Shionogi (搜索) Inc. announced that 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 with serious infections caused by susceptible Gram-negative bacteria. The application specifically covers hospital-acquired and ventilator-associated bacterial pneumonia (搜索) (HABP/VABP) and complicated urinary tract infections (搜索) (cUTI), including pyelonephritis (搜索), in pediatric patients at least 26 weeks of gestational age. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of February 23, 2027.
The submission aims to address a critical therapeutic gap for vulnerable young patients facing drug-resistant pathogens. Fetroja is already approved in the U.S. for the treatment of adult patients with cUTIs, including pyelonephritis (搜索), and HABP/VABP caused by certain susceptible Gram-negative bacterial infections.
Clinical Evidence Supporting the sNDA
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. These studies enrolled pediatric participants with cUTI, HABP/VABP, and other infections caused by suspected or confirmed Gram-negative bacteria.
The three pivotal studies are registered on ClinicalTrials.gov under identifiers NCT04215991, NCT04335539, and NCT06086626. Together, they provide a comprehensive assessment of cefiderocol's profile across the pediatric age spectrum, from neonates and infants through adolescents.
WHO Recognition and Unmet Need
In 2023, cefiderocol was included in the World Health Organization's PAediatric Drug Optimization (PADO) priority list. This list identifies medicines most urgently needed for children, particularly where there are gaps in dosing, safety data, or age-appropriate formulations. The inclusion underscores the global recognition of the need for effective antibiotics against Gram-negative pathogens in pediatric populations, where treatment options remain severely limited.
BARDA Partnership
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 (搜索)'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, under Contract No. 75A50126C00004.
Shionogi (搜索)'s Commitment to Infectious Disease
Shionogi (搜索) has discovered and commercialized six novel antibiotics over the past 70 years. The company's global pipeline includes investigational agents targeting antimicrobial resistance, COVID-19, influenza, rare fungal diseases, and respiratory syncytial virus. Shionogi ranked second among large research-based pharmaceutical companies in the Access to Medicine Foundation's 2026 Antimicrobial Resistance (AMR) Benchmark, reflecting its leadership in tackling antimicrobial resistance and expanding responsible access to antibiotics worldwide.
The company also partners with non-governmental organizations, including the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI), to improve access to antibiotics in low-, lower-middle-, and upper-middle-income countries, as well as select high-income countries.