Cefiderocol

ESCMID Global 2024: Shionogi presents real-world data demonstrating efficacy of Fetcroja® / Fetroja® (cefiderocol) in critically ill patients with certain difficult-to-treat bacterial infections

Retrieved on: 
Thursday, April 18, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Stenotrophomonas maltophilia, Mortality, Genetically modified bacteria, Cefiderocol, Safety, Kidney disease, Infection, Survival, Immunosuppression, Diabetes, Pseudomonas aeruginosa, ECCMID, Head, Urinary tract infection, CHAI, Patient, Hospice and palliative medicine, Gram-negative bacteria, Klebsiella pneumoniae, Chronic obstructive pulmonary disease, Pharmaceutical industry

Please see below under About Cefiderocol for full indications of Fetroja in the U.S.

Key Points: 
  • Please see below under About Cefiderocol for full indications of Fetroja in the U.S.
  • Additionally,19.5% of patients had polymicrobial infections.1
    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.
  • Real-world evidence is particularly important when reviewing antibiotic use for multidrug-resistant pathogens because of the challenges of conducting randomized clinical trials.
  • We also know how important it is to ensure equitable, global, access to essential medicines like cefiderocol.

IDWeek 2023: Shionogi Presents New Real-World Evidence Demonstrating Effectiveness of Earlier Treatment with Fetroja® (cefiderocol) in Appropriate Patients

Retrieved on: 
Wednesday, October 11, 2023
Hospitals, Pharmaceutical, Health, Clinical Trials, Infection, Klebsiella pneumoniae, FRCP, Senior, COVID-19, Cutis, Doctor of Philosophy, Drug, Research, Acinetobacter baumannii, Albany College of Pharmacy and Health Sciences, Death, Mortality, Safety, Outline of health sciences, Pseudomonas aeruginosa, Diabetes, Associate professor, Heart, Head, Kidney, RWE, RCT, Stenotrophomonas maltophilia, Blood, Urinary tract infection, Doctor of Pharmacy, Patient, AMR, Pharmaceutical industry, Vaccine, Nursing, Cefiderocol, MD, Klebsiella, Bachelor of Medicine, Bachelor of Surgery, Shionogi

“Seriously ill patients are often not represented in randomized clinical trials due to the difficulty with interpreting outcomes in such confounding situations.

Key Points: 
  • “Seriously ill patients are often not represented in randomized clinical trials due to the difficulty with interpreting outcomes in such confounding situations.
  • The patients included in this analysis were generally seriously ill and half (53.1%) were in the intensive care unit.
  • The most common pathogens identified among patients were Pseudomonas aeruginosa (48.7%), Acinetobacter baumannii (23.6%), Klebsiella pneumoniae (14.2%), and Stenotrophomonas maltophilia (13.1%).
  • Fetroja was used as monotherapy in 33% of patients (n=92), though most patients (92%, n=253) had received other antibiotics prior to Fetroja.

ECCMID 2023: Shionogi Announces Real-World Evidence Demonstrating the Efficacy of Fetcroja® / Fetroja® (cefiderocol) Against Some of the Most Difficult-to-Treat Gram-Negative Bacterial Pathogens

Retrieved on: 
Monday, April 17, 2023
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Interim, University, Head, Consultant, Infection, AMR, Fungal infection, Cutis, Acinetobacter baumannii, Urinary tract infection, Pseudomonas aeruginosa, Congress, Death, Cefiderocol, ECCMID, Patient, European, Mortality, Intensive care medicine, Gram-negative bacteria, Salvage therapy, Pharmaceutical industry, Vaccine, EU, Shionogi

These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support.

Key Points: 
  • These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support.
  • Cefiderocol was initiated for a documented pathogen in the majority of cases (77%), and as monotherapy in 57% of patients.
  • Cefiderocol achieved clinical cure in 60% of patients, and 76% of patients were alive within 30-days of starting treatment.
  • Cefiderocol was targeted as first treatment or as salvage therapy in 93% of patients, and as monotherapy in 41% of patients.

ECCMID 2023: Shionogi Announces Real-World Evidence Demonstrating the Efficacy of Fetcroja® (cefiderocol) Against Some of the Most Difficult-to-Treat Gram-Negative Bacterial Pathogens

Retrieved on: 
Monday, April 17, 2023
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Interim, University, Head, Consultant, Infection, AMR, Fungal infection, Cutis, Acinetobacter baumannii, Urinary tract infection, Pseudomonas aeruginosa, Congress, Death, Cefiderocol, ECCMID, Patient, European, Mortality, Intensive care medicine, Gram-negative bacteria, Salvage therapy, Pharmaceutical industry, Vaccine, EU, Shionogi

These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support.

Key Points: 
  • These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support.
  • Cefiderocol was initiated for a documented pathogen in the majority of cases (77%) and as monotherapy in 57% of patients.
  • Cefiderocol achieved clinical cure in 60% of patients, and 76% of patients were alive within 30-days of starting treatment.
  • Cefiderocol was targeted as first treatment or as salvage therapy in 93% of patients, and as monotherapy in 41% of patients.

Shionogi’s Antibiotic, FETCROJA® (cefiderocol), Is Now Available in the Netherlands

Retrieved on: 
Thursday, February 23, 2023
Infectious Diseases, Pharmaceutical, Health, Pseudomonas aeruginosa, AMR, Food, World Health Organization, Stenotrophomonas maltophilia, European Medicines Agency, Research, NADP, Gram-negative bacteria, Patient, Infection, Environment, Government, Cefiderocol, Bacteria, Pharmaceutical industry, Shionogi

Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter "Shionogi"), today announces that its antibiotic, cefiderocol, is now available in the Netherlands for the treatment of infections due to aerobic Gram-negative bacteria in adults (18 years or older) with limited treatment options.1

Key Points: 
  • Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter "Shionogi"), today announces that its antibiotic, cefiderocol, is now available in the Netherlands for the treatment of infections due to aerobic Gram-negative bacteria in adults (18 years or older) with limited treatment options.1
    Cefiderocol is available to purchase in the Netherlands through Alloga (Nederland) B.V.
  • The Netherlands, home to Shionogi’s European Headquarters, keeps AMR high on their political agenda.
  • Shionogi is proud to be one of the few large pharmaceutical companies that continues 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.10

Shionogi’s Innovative Antibiotic, FETCROJA® (cefiderocol), Is Now Available in Norway

Retrieved on: 
Wednesday, January 18, 2023
Pharmaceutical, Health, Clinical Trials, Animal, Infection, News, Cell, Engine Company 21 (Chicago), World Health Organization, COVID-19, AMR, WHO, Microbiology Society, AMPC, Beta-lactam, Penicillin-binding proteins, National Strategy to Secure Cyberspace, Pseudomonas aeruginosa, Bacteria, Vaccine, CR, Death, Patient, Research, Mortality, Stenotrophomonas maltophilia, Enzyme, Human, Gram-negative bacteria, Esbly, Cefiderocol, European Commission, Alliance Healthcare, Pharmaceutical industry, Distribution (marketing), Antibiotics, Shionogi

Since its European Commission approval in 2020, over 23,000 patients in total have now been treated with cefiderocol throughout Europe.

Key Points: 
  • Since its European Commission approval in 2020, over 23,000 patients in total have now been treated with cefiderocol throughout Europe.
  • 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 continues 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.21

SHIONOGI SIGNS AGREEMENT WITH NHS ENGLAND TO BEGIN AN INNOVATIVE SUBSCRIPTION PAYMENT MODEL FOR REIMBURSEMENT OF ITS ANTIBIOTIC, FETCROJA®▼ (CEFIDEROCOL)

Retrieved on: 
Wednesday, June 15, 2022
Health, Infectious Diseases, Research, Pharmaceutical, Science, Biotechnology, Penicillin-binding proteins, CNS, World, Degenerative disease, BSI, Infection, Death, Gastroenterology, Central nervous system disease, Gram-negative bacteria, NHS, AMR, Sepsis, VAP, Research, Stenotrophomonas maltophilia, Beta-lactam, CR, Marketing, Subclinical infection, Pain, Pseudomonas aeruginosa, Health, Intention, World Health Organization, SVP, Multidrug-resistant bacteria, Medicine, Patient, The Problem of Cell 13, NICE, Cell, HAP, NHS England, Antibiotics, Pharmaceutical industry, Risk management, Vaccine, Shionogi, Cefiderocol

Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter "Shionogi"), today announced that Shionogi B.V. had signed an agreement with NHS England to begin an innovative subscription payment model reimbursement of Cefiderocol in England.

Key Points: 
  • Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter "Shionogi"), today announced that Shionogi B.V. had signed an agreement with NHS England to begin an innovative subscription payment model reimbursement of Cefiderocol in England.
  • Once launched, there is often a low frequency of use driven by the need for stewardship to prevent resistance development.
  • Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years.
  • Shionogi B.V. is the European headquarters of Shionogi & Co., Ltd. For more information on Shionogi B.V., please visit www.shionogi.eu .

Shionogi to Present New Data on FETROJA® (cefiderocol) at IDWeek 2020

Retrieved on: 
Monday, October 19, 2020
Biotechnology, General Health, Pharmaceutical, Health, Chemical compounds, Organic compounds, Cefiderocol, Siderophores, Carbapenem, Shionogi, Carbapenem antibiotics, Pyrrolidines, Ertapenem, Antibiotic, Beta-lactam, FETROJA® (cefiderocol) for injection, Shionogi

Shionogi & Co., Ltd. (hereafter Shionogi) today announces that 18 abstracts on FETROJA (cefiderocol), including two oral presentations, will be shared at IDWeek.

Key Points: 
  • Shionogi & Co., Ltd. (hereafter Shionogi) today announces that 18 abstracts on FETROJA (cefiderocol), including two oral presentations, will be shared at IDWeek.
  • FETROJA has also demonstrated in vitro activity against certain bacteria that contain very problematic resistant enzymes such as ESBLs, AmpC, serine- and metallo-carbapenemases.
  • 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.
  • Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd. based in N.J. For more information on Shionogi Inc., please visit www.shionogi.com .

Shionogi Announces Publication of Two Studies in The Lancet Infectious Diseases Highlighting the Efficacy and Safety of FETROJA® for the Treatment of Infections Due to Aerobic Gram-negative Bacteria in Adults With Limited Treatment Options

Retrieved on: 
Tuesday, October 13, 2020
Health, Infectious diseases, Other Health, General Health, Clinical trials, Pharmaceutical, Biotechnology, Cefiderocol, Siderophores, Shionogi, Antibiotic, Pathogen, Drugs, Health, Medicine, Cefiderocol, Siderophores, Shionogi, Antibiotic, Pathogen, Drugs, Health, Medicine

Globally, approximately 700,000 people die as a result of infections caused by resistant pathogens every year.

Key Points: 
  • Globally, approximately 700,000 people die as a result of infections caused by resistant pathogens every year.
  • 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.
  • BAT regimens varied according to local practices and consisted of 1 to 3 antibacterial drugs with activity against Gram-negative bacteria.
  • Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd. based in N.J. For more information on Shionogi Inc., please visit www.shionogi.com .

Shionogi Announces Publication of Two Studies in the Lancet Infectious Diseases Highlighting the Efficacy and Safety of Cefiderocol for the Treatment of Infections Due to Aerobic Gram-negative Bacteria in Adults With Limited Treatment Options

Retrieved on: 
Tuesday, October 13, 2020
Health, Infectious diseases, Hospitals, Clinical trials, Pharmaceutical, Biotechnology, Medicine, Health, Clinical medicine, Cefiderocol, Siderophores, Healthcare-associated infections, Medical terminology, Beta-lactamase, Acinetobacter, Combination therapy

BAT was combination therapy in 71% (27/38) of cases with 28 different BAT regimens being used, whereas 83% (66/80) of cefiderocol treatment was monotherapy.

Key Points: 
  • BAT was combination therapy in 71% (27/38) of cases with 28 different BAT regimens being used, whereas 83% (66/80) of cefiderocol treatment was monotherapy.
  • The clinical and microbiological outcomes were generally similar between cefiderocol and BAT, except for metallo-beta-lactamases infections where cefiderocol was substantially better (cefiderocol: 75% and 44%; BAT: 29% and 14%, respectively).
  • There was an observed mortality difference between treatment arms in the subset of patients with Acinetobacter spp.
  • Cefiderocol received European Commission (EC) marketing authorisation for the treatment of infections due to aerobic Gram-negative bacteria in adults with limited treatment options under the brand name FETCROJA in April 2020 and is now commercially available in the UK.