Shionogi presents largest global real-world evidence study of cefiderocol

Japanese drug major Shionogi (TYO: 4507) has announced new data at IDWeek 2024 from PROVE (Retrospective Cefiderocol Chart Review), the largest global real-world evidence study of Fetroja/Fetcroja (cefiderocol), an innovative siderophore cephalosporin, for the treatment of seriously ill adult patients with certain Gram-negative (GN) bacterial infections, the majority of which were carbapenem-resistant (CR).

PROVE is an international, multicenter, retrospective medical chart review study designed to describe the patient characteristics and clinical outcomes in patients treated with cefiderocol for GN bacterial infections in real-world settings between 2020 and 2024. Of the patients included in the analysis, 75.1% had a favorable clinical response to cefiderocol at the end of treatment (defined as resolution or improvement of signs and symptoms as judged by the physician, excluding deaths while on therapy).

“Seriously ill patients with resistant Gram-negative bacterial infections are often difficult to treat. Although antibiotics are usually approved based on data from randomized controlled clinical trials, clinicians often rely on real-world evidence data to understand how antibiotics may perform in clinical settings,” said Dr Cornelius (Neil) Clancy, Professor of Medicine, University of Pittsburgh, adding: “This real-world evidence from PROVE, the largest to date for cefiderocol, further support its use and importance as a treatment option for appropriate patients with carbapenem-resistant Gram-negative infections in clinical settings.”