OSAKA, Japan and FLORHAM PARK, N.J., Sept. 28, 2021 – Shionogi & Co., Ltd. (hereafter “Shionogi”) today announces that 11 abstracts on FETROJA® (cefiderocol) will be shared at IDWeek. The meeting will take place virtually from Sept. 29 – Oct. 3, 2021.
“The data presented at IDWeek underscores our commitment to fighting antimicrobial resistance and addressing the challenges in treating carbapenem-resistant Gram-negative bacteria, which are associated with high mortality and unmet need,” said Akira Kato, Ph.D., President and CEO at Shionogi Inc. “We look forward to sharing new real-world data on FETROJA with the infectious disease community at IDWeek.”
Presentations will include data from company-sponsored or investigator-initiated studies. Abstracts will be available in the IDWeek Interactive Program and include:
Susceptibility of Phenotypic Subsets of Pseudomonas aeruginosa isolates of Cefiderocol and Comparator Agents from SIDERO-WT 2014-2019.
Presenter: Sean Nguyen, Pharm.D.
In Vitro and in Vivo Antibacterial Activity of Cefiderocol against Burkholderia spp.
Presenter: Merime Ota, BSc
Efficacy of Cefiderocol in Experimental Stenotrophomonas maltophilia Pneumonia in Persistently Neutropenic Rabbits.
Presenter: Vidmantas Petraitis, M.D.
In Vitro and in Vivo Antimicrobial Activity of Cefiderocol and Comparators against Achromobacter spp.
Presenter: Ryuichiro Nakai, MSc
Evaluation of Penetration of Cefiderocol into Cerebrospinal Fluid Using a Rat Meningitis Model.
Presenter: Miki Takemura, M.S.
In Vitro Activity of Cefiderocol and Comparator Agents against Molecularly-characterized Carbapenem-resistant Enterobacterales Clinical Isolates Causing Infection in United States Hospitals (2020)
Presenter: Rodrigo E. Mendes, Ph.D.
Clinical Response by Minimum Inhibitory Concentrations in Carbapenem-Resistant Pseudomonas aeruginosa Infections under Cefiderocol Compassionate Use Program.
Presenter: Michael Satlin, M.D.
Cefiderocol In Vitro Activity against Molecularly characterized Acinetobacter baumannii-calcoaceticus complex and Pseudomonas aeruginosa Clinical Isolates Causing Infection in United States Hospitals (2020).
Presenter: Rodrigo E. Mendes, Ph.D.
Double Disk Diffusion Study to Evaluate the Synergistic Effect Between Cefiderocol and Ceftazidime-Avibactam Against Cefiderocol-non-susceptible Acinetobacter baumannii.
Presenter: Yoshinori Yamano, Ph.D.
PROVE (Retrospective Cefiderocol Chart Review) Study of Real-World Outcomes and Safety in the Treatment of Patients with Gram-negative Bacterial Infections in the US and Europe.
Presenter: Stephen W. Marcella, M.D., M.P.H.
Activity of Cefiderocol and Comparators against Gram-negative Isolates from US Patients Hospitalized with Pneumonia.
Presenter: Dee Shortridge, Ph.D.
About FETROJA® (cefiderocol) for Injection
FETROJA® (cefiderocol) is a cephalosporin antibiotic with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore. In addition to entering cells by passive diffusion through porin channels, FETROJA binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria. These mechanisms allow FETROJA to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells. FETROJA has also demonstrated in vitro activity against certain bacteria that contain very problematic resistant enzymes such as ESBLs, AmpC, serine- and metallo-carbapenemases. Data from multinational surveillance studies for FETROJA demonstrated potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant A. baumannii, P. aeruginosa, Enterobacterales, and S. maltophilia. The clinical significance of the in vitro data is unknown. FETROJA has poor in vitro activity against Gram-positive or anaerobic bacteria.
Cefiderocol, under the brand name FETCROJA®, is approved by the European Commission for the treatment of infections due to aerobic Gram-negative bacteria in adults 18 years or older with limited treatment options.
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, caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.
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WARNINGS AND PRECAUTIONS
Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections
An increase in all-cause mortality was observed in patients treated with Fetroja as compared to best available therapy (BAT) in a multinational, randomized, open-label trial in critically ill patients with carbapenem-resistant Gram-negative bacterial infections (NCT02714595). Patients with nosocomial pneumonia, bloodstream infections, sepsis, or cUTI were included in the trial. BAT regimens varied according to local practices and consisted of 1 to 3 antibacterial drugs with activity against Gram-negative bacteria. Most of the BAT regimens contained colistin.
The increase in all-cause mortality occurred in patients treated for nosocomial pneumonia, bloodstream infections, or sepsis. The 28-Day all-cause mortality was higher in patients treated with Fetroja than in patients treated with BAT [25/101 (24.8%) vs 9/49 (18.4%), treatment difference 6.4%, 95% CI (-8.6, 19.2)]. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49 [34/101 (33.7%) vs 10/49 (20.4%), treatment difference 13.3%, 95% CI (-2.5, 26.9)]. 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.
For Full US Prescribing Information, please visit Shionogi.com.
Shionogi’s commitment to fighting antimicrobial resistance
Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continue to focus on research and development in anti-infectives. The company invests the highest proportion of its pharmaceutical revenues in relevant anti-infectives R&D compared to other large pharmaceutical companies.
For more information, please refer to: https://www.shionogi.com/global/en/sustainability/amr.html
Forward Looking Statement
For further information, contact:
Lindsay Bohlander, Senior Director, Corporate Planning & Communications