FLORHAM PARK, N.J., July 16, 2026

Shionogi Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for Fetroja® (cefiderocol) to expand its use to pediatric patients aged at least 26 weeks of gestational age for the treatment of hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and complicated urinary tract infections (cUTIs), including pyelonephritis, caused by susceptible Gram-negative bacteria. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027.

Clinical Studies Support Pediatric Label Expansion

The sNDA is supported by data from three clinical studies involving 154 pediatric patients, ranging from newborns (at least 26 weeks gestational age) to under 18 years old. The studies evaluated the safety, tolerability, pharmacokinetics, and efficacy of cefiderocol in treating complicated urinary tract infections, HABP/VABP, and other infections caused by suspected or confirmed Gram-negative pathogens.

Addressing a Critical Pediatric Treatment Gap

Fetroja was added to the World Health Organization’s Pediatric Drug Optimization (PADO) priority list in 2023, highlighting its importance in addressing unmet needs for pediatric treatments against antimicrobial-resistant infections. The proposed label expansion also supports ongoing efforts to improve treatment options for children facing serious infections caused by multidrug-resistant Gram-negative bacteria.

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Expanding Shionogi’s Infectious Disease Portfolio

Fetroja is currently approved in the United States for treating adult patients with complicated urinary tract infections and hospital-acquired or ventilator-associated bacterial pneumonia caused by susceptible Gram-negative bacteria. Development of the pediatric HABP/VABP indication is supported through a BARDA Project BioShield contract with the U.S. government. Shionogi continues to expand its infectious disease pipeline while advancing therapies targeting antimicrobial resistance, HIV, influenza, COVID-19, respiratory syncytial virus (RSV), and rare fungal diseases.

Source: Shionogi press release