ESCMID Global 2025: Shionogi presents real-world data demonstrating better clinical outcomes when Fetcroja® / Fetroja® (cefiderocol) is used as empiric or documented therapy as compared to salvage therapy for the treatment of Gram-negative bacterial infections

• Data from five European countries demonstrates the effectiveness of cefiderocol against Gram-negative pathogens considered as high or critical priorities by the WHO, including high rates of clinical cure and day 28 survival across patients with limited treatment options
• New European cohort data from the largest real-world evidence study of cefiderocol indicates a lower clinical cure rate trend among patients who received cefiderocol as salvage therapy compared with patients who received documented or empirical treatment.

8 April 2025 -- Osaka, Japan -- Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) presents new European data from its largest real-world evidence study of Fetroja®/Fetcroja® (cefiderocol), an innovative siderophore cephalosporin at the 35th Congress of the European Society of Clinical Microbiology and Infectious Diseases in Vienna on 11th-15th April 2025.

The PROVE (Retrospective Cefiderocol Chart Review) study is a five-year international, retrospective, observational medical chart review study, conducted between November 2020 and July 2024 designed to describe the efficacy and safety of real-world cefiderocol use in adult patients with serious Gram-negative (GN) bacterial infections.

Analysis of the European cohort found a higher clinical cure rate trend among patients who received cefiderocol for a documented infection (67.4%) or as empiric therapy (64.6%) as compared to those who received it as salvage therapy (58.2%).

Professor Oliver Cornely, Director of Translational Research, University of Cologne, said: “These data suggest a trend towards worse clinical outcomes when the use of cefiderocol to treat Gram-negative bacterial infections is reserved as a last line treatment option compared with those who received the treatment earlier. This trend may offer clinicians new evidence to justify the early and effective use of cefiderocol in patients with suspected resistant infections.”

The study analysed data from 567 patients hospitalised with confirmed GN bacterial infections, who were treated with cefiderocol for the first time for ≥72 hours across Spain, France, Italy, Germany and the United Kingdom.1 Carbapenem resistance rate was >70% among patients enrolled in the study.1 55.9% of patients were critically ill in the intensive care unit and 41.3% were receiving organ support at the point of cefiderocol initiation.

Respiratory tract infection (RTI) was the most frequent infection site, reported in over 50% patients (299), followed by urinary tract infection in over 12% of patients (73).
Patients in the study receiving cefiderocol across all pathogens achieved an overall clinical cure rate of 65.3%. The most frequent pathogens observed were Pseudomonas aeruginosa (41.3%), Acinetobacter baumannii (15.0%), and Enterobacterales (14.6%), which are identified as priority pathogens by the World Health Organisation. A clinical cure rate of 73.1% was observed among patients with a Pseudomonas aeruginosa infection.

Takuko Sawada, Board Director and Vice Chair, Shionogi & Co Ltd., said: “Antimicrobial resistance is one of the most pressing global health challenges of this century, resulting in the deaths of millions of people around the world each year. In order to support better patient outcomes, it is imperative that clinicians have access to the innovative treatments they need for appropriate use with the right patient at the right time. We remain committed to the research and development of essential medicines that will help tackle the growing threat of drug-resistant infection.”

About Shionogi & Co. Ltd
Shionogi & Co., Ltd. is a 147-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders, cardiovascular diseases and gastroenterology. Shionogi’s research and development currently target two therapeutic areas: infectious diseases, and pain/CNS disorders.
For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en.