New data from the largest European real-world evidence study of cefiderocol demonstrate positive outcomes including high rates of clinical success and day 28 survival across Gram-negative pathogens considered as critical priorities by the WHO in patients with limited treatment options1, 2
OSAKA, Japan, APRIL 18, 2024 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announces new data from the largest European real-world evidence study (PERSEUS) of Fetroja®/Fetcroja® (cefiderocol), an innovative siderophore cephalosporin, for the treatment of critically ill patients with carbapenem-resistant (CR) Gram-negative (GN) bacterial infections at the 34th ESCMID Global (formerly ECCMID) in Barcelona, 27–30 April, 2024.
The study included 261 critically ill adult patients with limited treatment options who received cefiderocol for less than 28 days as part of Shionogi’s Early Access Program in Spain. Of these, 64.8% were resistant to all tested antibiotics and 44.4% experienced treatment failure with prior antibiotics.1 The patients received cefiderocol consecutively for ≥72 hours for a confirmed GN bacterial infection. The patients included in the analysis were critically ill with nearly two-thirds (63.2%) in the intensive care unit, 47.1% on mechanical ventilation and 28% with septic shock.1 In addition to GN bacterial infections, patients also had serious comorbidities including immunosuppression (30.3%), solid or hematological tumors (23.8%), diabetes (22.2%), transplant (20.7%), chronic renal disease (13.0%) and chronic obstructive pulmonary disease (10.3%).1
Dr. Alex Soriano, Head of Infectious Diseases Service at Hospital Clinic in Barcelona, says: “The increasing resistance of Gram-negative bacterial infections to current therapies makes them difficult to treat. Real-world evidence is particularly important when reviewing antibiotic use for multidrug-resistant pathogens because of the challenges of conducting randomized clinical trials. These new data reinforce the importance of cefiderocol and contribute to the growing body of real-world evidence in patient care for those with difficult-to-treat pathogens that were resistant to other antibiotics.”
We also know how important it is to ensure equitable, global, access to essential medicines like cefiderocol. That’s why we are working with like-minded partners GARDP and CHAI, to support the availability of this important antibiotic for people living in low- and middle-income countries.”
About Shionogi & Co. Ltd.
About Shionogi in AMR
About Cefiderocol
U.S. INDICATIONS
USAGE
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections
Hypersensitivity Reactions
Clostridioides difficile-associated Diarrhea (CDAD)
Seizures and Other Central Nervous System (CNS) Adverse Reactions
Development of Drug-Resistant Bacteria
ADVERSE REACTIONS
Forward-Looking Statements
For Further Information, Contact:
SEU Press Office: pressoffice@shionogi.eu
U.S. Media Contact: ShionogiCommunications@shionogi.com