공시 • Apr 08
Shionogi & Co., Ltd. Presents New Real-World Data Highlighting Clinical Effectiveness of Fetroja/Fetcroja (Cefiderocol) in Mbl-Producing Enterobacterales Infections
Shionogi & Co., Ltd. presented new real-world data evaluating Fetroja/Fetcroja (cefiderocol), an innovative siderophore cephalosporin, in adults with confirmed MBL-producing Enterobacterales infections at the 36th Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in Munich, 17th-21st April, 2026. Cefiderocol is for the treatment of seriously ill adult patients with complicated urinary tract infections (cUTIs) and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain Gram-negative bacterial infections. The CIRCE study was a retrospective, observational, multicenter chart review study conducted in Spain between January 2023 and April 2025, designed to describe the effectiveness and safety of real-world cefiderocol use in 232 adult patients with infections caused by MBL-producing Enterobacterales. The analysis found 68% of patients who received cefiderocol were considered clinically cured at day 14 and 82% of patients achieved clinical response at day 14. The overall rates of survival at days 14 and 28 were 90% and 83%, respectively, in this population. At baseline, 29% of patients were immunosuppressed, 27% were in intensive care and 13% presented with septic shock. Drug associated adverse events were collected through routine chart review with no new identified safety signals beyond the established safety profile of cefiderocol. MBL-producing Enterobacterales inactivate almost all beta-lactam antibiotics, including carbapenems - agents typically reserved for severe or high-risk infections, thereby limiting therapeutic options. In the CIRCE study, the most frequently identified pathogens were carbapenem-resistant Klebsiella pneumoniae and Enterobacter spp. respectively, both classified by the World Health Organization as critical priority pathogens due to their high levels of resistance to currently available therapies. Among patients with available follow-up cultures, microbiological eradication rates were reported as 85% in bloodstream infections and 82% in urinary tract infections (UTIs). Approximately half of patients received cefiderocol based on susceptibility testing. Additional data presented at ESCMID 2026 evaluated the in vitro activity of cefiderocol against more than 4,000 Stenotrophomonas maltophilia clinical isolates collected through the multinational SIDERO-WT (2014–2019) and SENTRY (2020–2024) surveillance programmes. Across this 10-year period, there was no significant change in cefiderocol susceptibility observed before or after market introduction. Stenotrophomonas maltophilia is an opportunistic pathogen with high intrinsic resistance to multiple antimicrobial classes, often limiting treatment options in high-risk patients. Data presented at the same congress reinforced cefiderocol’s effectiveness against Stenotrophomonas maltophilia, with a subgroup analysis of 119 patients from the PROVE study demonstrating clinical cure in approximately two-thirds of patients, the majority of whom were critically ill and receiving care in intensive care units. In the U.S., cefiderocol is commercially available under the brand name Fetroja and is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and complicated urinary tract infections caused by certain susceptible Gram-negative microorganisms. In Europe, cefiderocol is commercially available under the brand name Fetcroja for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. In Japan, cefiderocol is commercially available under the brand name Fetroja and received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for various infections caused by strains resistant to carbapenem antibiotics among sensitive strains of Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia, and Acinetobacter species. Fetroja (cefiderocol) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. Fetroja is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Fetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja. An increase in 28-day all-cause mortality was observed in Fetroja-treated nosocomial pneumonia, bloodstream infections, or sepsis patients compared to those treated with best available therapy (BAT) in a clinical study. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49. Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established. Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP.
