The FDA has accepted Shionogi's supplemental New Drug Application (sNDA) for cefiderocol (Fetroja), seeking to expand the antibiotic's indication to include pediatric patients with serious infections caused by susceptible Gram-negative bacteria.
If approved, cefiderocol would be indicated for pediatric patients from birth (at least 26 weeks of gestational age) to younger than 18 years of age for the treatment of hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and complicated urinary tract infections (cUTIs), including pyelonephritis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027.
The application is supported by data from three clinical studies involving 154 pediatric patients, which evaluated the safety, tolerability, pharmacokinetics, and efficacy of cefiderocol in children with cUTIs, HABP/VABP, and other infections caused by suspected or confirmed Gram-negative pathogens.
The submission aims to address an unmet need for pediatric patients with severe infections caused by multidrug-resistant Gram-negative bacteria, a population with limited approved treatment options.
Further supporting the application, cefiderocol was included on the World Health Organization's 2023 Pediatric Drug Optimization (PADO) priority list, which identifies medicines that are urgently needed for children because of gaps in dosing, safety data, or age-appropriate formulations.
What You Need to Know
The FDA accepted the sNDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027.
The application seeks approval for Fetroja in patients from birth (at least 26 weeks of gestational age) through younger than 18 years with serious Gram-negative infections, an area with limited treatment options.
The submission is backed by three clinical studies evaluating safety, pharmacokinetics, tolerability, and efficacy in 154 pediatric patients, while cefiderocol was also recognized on the WHO's Pediatric Drug Optimization priority list in 2023.
Shionogi also noted that development of cefiderocol for pediatric HABP/VABP is supported through an ongoing contract with the Biomedical Advanced Research and Development Authority (BARDA) under Project BioShield, reflecting continued federal investment in expanding therapies for serious bacterial infections.
Cefiderocol is currently approved in the United States for adults with complicated urinary tract infections, including pyelonephritis, and hospital-acquired and ventilator-associated bacterial pneumonia caused by certain susceptible Gram-negative organisms. If the sNDA is approved, the antibiotic would become available for pediatric patients facing many of the same difficult-to-treat, drug-resistant infections.
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