FDA accepted Shionogi’s sNDA for cefiderocol for pediatric HABP/VABP and complicated UTI caused by certain Gram-negative bacteria.
The US Food and Drug Administration has accepted Shionogi’s supplemental New Drug Application for cefiderocol (Fetroja) for the treatment of pediatric patients with serious infections caused by certain susceptible Gram-negative bacteria, according to a company announcement.1
The proposed pediatric indication includes patients at least 26 weeks of gestational age with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated
The FDA set a Prescription Drug User Fee Act target action date of February 23, 2027.1
Cefiderocol is currently approved in the US for adults with cUTI, including pyelonephritis, and HABP/VABP caused by certain susceptible Gram-negative bacteria. The sNDA seeks to expand use into pediatric patients, a population with limited treatment options for serious drug-resistant infections.1
The submission was supported by results from 3 clinical studies that evaluated the safety, tolerability, pharmacokinetics, and efficacy of cefiderocol in 154 children from birth, defined as at least 26 weeks of gestational age, to younger than 18 years. The studies included pediatric patients with cUTI, HABP/VABP, and other infections caused by suspected or confirmed Gram-negative bacteria.2,3
The company stated that the submission is intended to address a therapeutic gap for vulnerable young patients facing drug-resistant pathogens. In 2023, cefiderocol was included in the World Health Organization’s Paediatric Drug Optimization priority list, which identifies medicines urgently needed for children, particularly when gaps remain in dosing, safety data, or age-appropriate formulations.1
For primary care clinicians, the regulatory update is most relevant in the broader context of
The potential expansion into pediatrics also underscores the need for continued antimicrobial stewardship, appropriate culture-directed therapy, and coordination between inpatient teams, infectious disease specialists, pharmacists, and primary care clinicians when children are discharged after serious bacterial infections.1
The expansion of cefiderocol for pediatric HABP/VABP is supported by an ongoing contract with the US government through the Biomedical Advanced Research and Development Authority’s Project BioShield.1
