Japan-based Shionogi & Co., Ltd. said the US FDA has accepted a Supplemental New Drug Application (sNDA) for cefiderocol (Fetroja), seeking to extend the antibiotic's use to pediatric patients as young as 26 weeks of gestational age with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative organisms.
The filing, submitted by the New Jersey arm of Shionogi, moves the Fetroja pediatric FDA approval process into formal review, with the FDA setting a PDUFA action date of February 23, 2027. Fetroja is currently approved in the US only for adults with these infections; the sNDA, if cleared, would make it one of the few novel antibiotics with a labeled indication for pediatric HABP/VABP.
The filing addresses a gap that has persisted since cefiderocol's 2019 approval. Companies developing antibiotics for multidrug-resistant Gram-negative bacterial infections treatment have historically prioritized adult registration trials, leaving clinicians to use these agents off-label in children based on extrapolated dosing. The World Health Organization flagged this gap explicitly, adding cefiderocol to its 2023 PAediatric Drug Optimization priority list, which identifies medicines urgently needed for children where dosing, safety, and formulation data are lacking.
Pediatric serious infections caused by drug-resistant Gram-negative bacteria, including carbapenem-resistant Enterobacterales, Acinetobacter baumannii, and Pseudomonas aeruginosa, present a narrower set of treatment options than in adults. Several newer beta-lactam/beta-lactamase inhibitor combinations, including ceftazidime-avibactam and ceftolozane-tazobactam, hold pediatric approvals for cUTI and complicated intra-abdominal infections but not for HABP/VABP. Others, such as imipenem-cilastatin-relebactam and meropenem-vaborbactam, remain restricted to adults across all indications. If the sNDA is cleared, cefiderocol would become one of the only novel antibiotics with a dedicated pediatric label covering hospital-acquired and ventilator-associated pneumonia, a niche where clinicians currently rely on carbapenems or off-label use of newer agents.