Shionogi’s Fetroja sNDA Accepted by FDA for Pediatric Hospital Pneumonia and Complicated UTIs

Shionogi has received U.S. Food and Drug Administration (FDA) acceptance of a Supplemental New Drug Application (sNDA) seeking to expand the indication for Fetroja (cefiderocol) to pediatric patients with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain Gram-negative microorganisms.

If approved, the expanded indication would cover children from birth, including neonates at least 26 weeks of gestational age, through younger than 18 years of age. The FDA has assigned a Prescription Drug User Fee Act target action date of February 23, 2027.

Addressing a Critical Need in Pediatric Drug-Resistant Infections

Cefiderocol is a siderophore cephalosporin antibiotic that enters Gram-negative bacteria by exploiting their iron transport systems, allowing it to overcome several resistance mechanisms. The therapy retains activity against many multidrug-resistant Gram-negative pathogens, including organisms that produce carbapenemases.

Serious Gram-negative infections remain a major challenge in hospitalized children, particularly those requiring intensive care or mechanical ventilation. Treatment options are limited because few antibiotics have been extensively studied or approved in pediatric populations, especially for infections caused by resistant bacteria.

The unmet need has been recognized globally. In 2023, the World Health Organization (WHO) added cefiderocol to its Paediatric Drug Optimization (PADO) priority list, highlighting medicines that require pediatric dosing, safety, and formulation data to improve treatment options for children.

 Clinical Evidence Supporting the Application

The pediatric sNDA is supported by data from three clinical studies evaluating cefiderocol in 154 pediatric patients, ranging from birth (at least 26 weeks of gestational age) to younger than 18 years.

The studies assessed the drug across patients with complicated urinary tract infections, HABP/VABP, and other suspected or confirmed Gram-negative bacterial infections.

Collectively, the trials evaluated:

• Safety and tolerability
• Pharmacokinetics across pediatric age groups
• Clinical efficacy in treating serious Gram-negative infections

The results generated the evidence package submitted to the FDA to support expanding the current U.S. label into pediatric populations.

Expanding an Established Adult Therapy

Fetroja 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 susceptible Gram-negative bacteria.

Approval of the pediatric indication would extend access to a therapy already used in adults for difficult-to-treat Gram-negative infections and provide clinicians with an additional treatment option for critically ill children.

Government Support for Pediatric Development

Development of Fetroja for pediatric HABP and VABP is supported through an ongoing contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) under Project BioShield. The program is funded by the U.S. Department of Health and Human Services through the Administration for Strategic Preparedness and Response and BARDA.

The collaboration reflects continued government investment in expanding access to antibacterial therapies for serious infections while strengthening preparedness against antimicrobial resistance.

Regulatory Path

With FDA acceptance of the supplemental application, Shionogi moves into the formal regulatory review phase. The agency is expected to complete its review by February 23, 2027.

A positive decision would expand Fetroja’s U.S. prescribing information to include pediatric patients with HABP, VABP, and complicated urinary tract infections, addressing an important treatment gap for severe Gram-negative bacterial infections in children.

Reference

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｜ SHIONOGI