Japan-based Shionogi has shared new real-world evidence showing its antibiotic cefiderocol leads to better outcomes when used early to treat serious gram-negative bacterial infections. Presented at European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2025 conference in Vienna, the Retrospective Cefiderocol Chart Review (PROVE) study found that earlier use of cefiderocol, rather than as a last resort, improves cure rates—offering hope in the ongoing fight against antimicrobial resistance (AMR), says GlobalData.
AMR and the development of new antimicrobials to help combat AMR were the key themes at the ESCMID Global 2025 conference. There were over 100 presentations on these topics, one of which was the noteworthy results of the PROVE study.
Shionogi’s cefiderocol, a cephalosporin that acts as a penicillin binding protein inhibitor, is marketed in the US, EU, and Japan under the brand names Fetcroja/Fetroja for the treatment of various gram-negative bacterial infections.
The PROVE study analysed over 560 patients in France, Germany, Italy, Spain, and the UK, who had serious gram-negative bacterial infections and were treated with cefiderocol for the first time for at least 72 hours.
The PROVE study showed a 65.3 per cent overall clinical cure rate and the 30-day all-cause mortality (ACM) rate was 25.7 per cent. Cure rates peaked in urinary tract infections (90.4 per cent) and Pseudomonas infections (73.1 per cent) and were lowest in respiratory tract infections (59.2 per cent) and Acinetobacter cases (50.6 per cent). Early use, empiric or targeted, yielded better outcomes than salvage therapy.
Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments, “The data presented by Shionogi at ESCMID Global 2025 demonstrates that cefiderocol is associated with better clinical outcomes when used earlier in treatment. This also suggests that cefiderocol has the potential to be a new and effective first-line therapy option, which could be particularly useful given the acceleration of AMR and the lack of effective treatment options for severe infections.”
According to the World Health Organization (WHO), bacterial pathogens of utmost public health importance to prevent and control AMR include Acinetobacter baumannii, Enterobacterales, and Pseudomonas aeruginosa, among others, all of which were analysed in the PROVE study and are highly susceptible to cefiderocol.
Kurdach concludes, “With rising AMR threats and limited treatment options, Shionogi’s data highlights cefiderocol’s potential as a frontline therapy—underscoring the urgency for global stewardship strategies that prioritise early intervention with effective antimicrobials.”