Cefiderocol

Shionogi Announces FDA Approval of FETROJA® (cefiderocol) for the Treatment of Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia

Retrieved on: 
Monday, September 28, 2020
Biotechnology, FDA, Pharmaceutical, Health, Medical specialties, RTT, Health, Medicine, Pyrrolidines, Carbapenem antibiotics, Infectious diseases, Meropenem, Shionogi, Urinary tract infection, Cefiderocol, Pyelonephritis, APEKS-NP, FETROJA® (cefiderocol) for injection, Shionogi

FETROJA is currently approved for patients 18 years of age or older for the treatment of complicated urinary tract infections, including pyelonephritis, caused by Gram-negative pathogens.

Key Points: 
  • FETROJA is currently approved for patients 18 years of age or older for the treatment of complicated urinary tract infections, including pyelonephritis, caused by Gram-negative pathogens.
  • Safety was investigated up to 28 days after the end of treatment unless there was an ongoing adverse event(s) which were followed up until their resolution.
  • The study found that FETROJA:
    Met the primary endpoint of non-inferiority to high-dose meropenem, infused over three hours.
  • 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 Launches FETCROJA® (cefiderocol) in the United Kingdom for the Treatment of Infections Due to Aerobic Gram-Negative Bacteria in Adults With Limited Treatment Options

Retrieved on: 
Tuesday, September 15, 2020
Health, Infectious diseases, Research, Pharmaceutical, Science, Biotechnology, Health, Medical specialties, Infectious diseases, Healthcare-associated infections, Shionogi, Carbapenem, Hospital-acquired infection, Cefiderocol, Hospital-acquired pneumonia

Cefiderocol can now be used to treat some of the most life-threatening infections in patients for whom there are limited or no alternative treatment options.

Key Points: 
  • Cefiderocol can now be used to treat some of the most life-threatening infections in patients for whom there are limited or no alternative treatment options.
  • Similar to nosocomial pneumonia patients with carbapenem-resistant Gram-negative infections, cefiderocol may be considered as a treatment option.
  • 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 Granted New Technology Add-on Payment For FETROJA® (Cefiderocol) by CMS

Retrieved on: 
Thursday, September 3, 2020
Oncology, Health, Infectious diseases, Hospitals, Managed care, Pharmaceutical, Biotechnology, Federal assistance in the United States, Healthcare reform in the United States, Presidency of Lyndon B. Johnson, Shionogi, Cefiderocol, Medicaid, Medicare, Health, Companies, Articles

Shionogi & Co., Ltd. (hereafter Shionogi) today announces that the Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for FETROJA (cefiderocol) when administered in the hospital inpatient setting.

Key Points: 
  • Shionogi & Co., Ltd. (hereafter Shionogi) today announces that the Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for FETROJA (cefiderocol) when administered in the hospital inpatient setting.
  • CMS has assigned a maximum payment of $7,919.86 for a patient treated with FETROJA.
  • FETROJA is contraindicated in patients with a known history of severe hypersensitivity to FETROJA 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 Receives European Commission Marketing Authorisation for FETCROJA® (cefiderocol) for the Treatment of Infections Due to Aerobic Gram-negative Bacteria in Adults With Limited Treatment Options

Retrieved on: 
Tuesday, April 28, 2020
Biotechnology, Pharmaceutical, Health, Clinical trials, Medical specialties, Health, Medicine, Infectious diseases, Healthcare-associated infections, Carbapenem antibiotics, Pneumonia, Carbapenem, Hospital-acquired pneumonia, Hospital-acquired infection, Cefiderocol, Shionogi, Antimicrobial Resistance, cefiderocol access, Shionogi

As a result of COVID-19 some ventilated patients with viral pneumonia may develop secondary carbapenem-resistant Gram-negative bacterial infections.

Key Points: 

U.S. FDA Advisory Committee Recommends Approval of Cefiderocol for Treatment of Complicated Urinary Tract Infections

Retrieved on: 
Wednesday, October 16, 2019
General Health, FDA, Infectious diseases, Health, Pharmaceutical, Medical specialties, Medicine, Health, RTT, Urinary tract infection, Antibiotic, Cephalosporin, Shionogi, Cefiderocol, Pyelonephritis, Plazomicin, Cefiderocol–An Investigational Antibiotic Agent, Gram-negative Infections, Shionogi

Shionogi & Co., Ltd. (hereafter Shionogi) today announced that the U.S. Food and Drug Administrations (FDA) Antimicrobial Drugs Advisory Committee voted to recommend approval of the investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options.

Key Points: 
  • Shionogi & Co., Ltd. (hereafter Shionogi) today announced that the U.S. Food and Drug Administrations (FDA) Antimicrobial Drugs Advisory Committee voted to recommend approval of the investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options.
  • We are pleased with the positive recommendation for the approval of cefiderocol for the treatment of cUTI.
  • If approved, we believe cefiderocol could help address a significant unmet need in an area with limited treatment options to fight these life-threatening infections.
  • Cefiderocol is a siderophore cephalosporin with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens including multidrug-resistant strains.

Shionogi Reports Positive Results from Cefiderocol Phase III Study in Adults with Nosocomial Pneumonia Caused by Gram-negative Pathogens

Retrieved on: 
Wednesday, October 9, 2019
Health, Hospitals, Clinical trials, Pharmaceutical, Biotechnology, Medicine, Health, Medical specialties, Infectious diseases, Pyrrolidines, Carbapenem antibiotics, RTT, Hospital-acquired pneumonia, Pneumonia, Cefiderocol, Hospital-acquired infection, Cephalosporin, APEKS-NP, Cefiderocol–An Investigational Antibiotic Agent, Gram-negative Infections, Shionogi

Shionogi & Co., Ltd. (hereafter Shionogi) announces results from APEKS-NP, an international, double-blind, randomized Phase III clinical trial evaluating the efficacy and safety of the investigational antibiotic cefiderocol in patients with nosocomial pneumonia (NP).

Key Points: 
  • Shionogi & Co., Ltd. (hereafter Shionogi) announces results from APEKS-NP, an international, double-blind, randomized Phase III clinical trial evaluating the efficacy and safety of the investigational antibiotic cefiderocol in patients with nosocomial pneumonia (NP).
  • Cefiderocol is a siderophore cephalosporin with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens including multidrug-resistant strains.
  • Patients with serious infections caused by resistant Gram-negative pathogens are facing a most serious challenge with high morbidity and mortality rates.
  • LB4 - Efficacy and Safety of Cefiderocol versus High-Dose Meropenem in Patients with Nosocomial Pneumonia Results of a Phase 3 Randomized, Multicenter, Double-Blind, Non-Inferiority Study.

Shionogi Reports Positive Results from Cefiderocol Phase III Study in Adults with Pneumonia Caused by Gram-negative Pathogens

Retrieved on: 
Wednesday, October 2, 2019
Science, Pharmaceutical, Research, Health, Infectious diseases, Clinical trials, Branches of biology, Organisms, Chemistry, Cefiderocol, Siderophores, Cephalosporin, Siderophore, Gram-negative bacteria, Multiple drug resistance, Pseudomonas aeruginosa, Carbapenem

Cefiderocol is a siderophore cephalosporin with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens including multidrug-resistant strains.

Key Points: 
  • Cefiderocol is a siderophore cephalosporin with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens including multidrug-resistant strains.
  • Patients with serious infections caused by resistant Gram-negative pathogens are facing a most serious challenge with high morbidity and mortality rates.
  • Cefiderocol is a siderophore cephalosporin with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens including multidrug-resistant strains.
  • 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 to Present New Data at IDWeek 2019

Retrieved on: 
Thursday, September 26, 2019
Infectious diseases, FDA, Clinical trials, Biotechnology, Pharmaceutical, Health, Oncology, Organic compounds, Chemical compounds, Heterocyclic compounds, Genentech, Antivirals, Shionogi, Baloxavir marboxil, Carbapenem antibiotics, RTT, Cefiderocol, Carbapenem, Influenza

Additionally, Shionogi will share findings from other studies investigating cefiderocol, and the prevalence and characterization of carbapenem-resistant bacterial infections.

Key Points: 
  • Additionally, Shionogi will share findings from other studies investigating cefiderocol, and the prevalence and characterization of carbapenem-resistant bacterial infections.
  • Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd. based in N.J. For more information on Shionogi Inc., please visit https://www.shionogi.com/ .
  • Shionogi & Co, Ltd. Shionogi Announces FDA Approval of XOFLUZATM (Baloxavir Marboxil) - for the Treatment of Acute, Uncomplicated Influenza.
  • Shionogi & Co, Ltd. Shionogi Announces Positive Post-Exposure Prophylaxis Results for XOFLUZA in Phase III Study (BLOCKSTONE) of Influenza Virus Infection in Household Members.

Shionogi to Present Cefiderocol and COT-143 Data at American Society for Microbiology Microbe 2019 Meeting

Retrieved on: 
Monday, June 17, 2019
Stem cells, Health, Biotechnology, Cardiology, Clinical trials, Hospitals, Infectious diseases, Oncology, Pharmaceutical, FDA, Cefiderocol, Siderophores, Drugs, Shionogi, Monoclonal antibodies, Companies, Chemical substances

Shionogi & Co., Ltd. (hereafter Shionogi) today announced there will be one oral presentation and 17 poster presentations featuring two of the companys investigational compounds at the American Society for Microbiology (ASM) Microbe meeting, being held June 2024, 2019 in San Francisco.

Key Points: 
  • Shionogi & Co., Ltd. (hereafter Shionogi) today announced there will be one oral presentation and 17 poster presentations featuring two of the companys investigational compounds at the American Society for Microbiology (ASM) Microbe meeting, being held June 2024, 2019 in San Francisco.
  • Sixteen poster presentations are on cefiderocol, a late-stage investigational, novel siderophore cephalosporin, and one is on COT-143, a humanized monoclonal antibody.
  • In addition, Shionogi will also present a poster on COT-143, an investigational humanized monoclonal antibody demonstrating anti-virulence activity targeting the PcrV protein of Pseudomonas aeruginosa.
  • Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd. based in N.J. For more information on Shionogi Inc., please visit https://www.shionogi.com/ .

Shionogi Announces Data Demonstrating Potent in Vitro Activity of Cefiderocol against the Most Critical Priority Gram-Negative Bacterial Pathogens

Retrieved on: 
Monday, April 15, 2019
Health, Biotechnology, Clinical trials, Hospitals, Infectious diseases, Medical devices, Pharmaceutical, Carbapenem, Gram-negative bacteria, Enterobacteriaceae, Cephalosporin, Siderophore, Cefiderocol, Chemical compounds, Chemistry, Branches of biology

Cefiderocol is a parenteral siderophore cephalosporin with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens including multidrug-resistant strains.

Key Points: 
  • Cefiderocol is a parenteral siderophore cephalosporin with a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens including multidrug-resistant strains.
  • Two Phase III studies are ongoing in patients with HAP/VAP/HCAP (APEKS-NP) and with carbapenem-resistant pathogens at various infection sites (CREDIBLE-CR).
  • Cefiderocol in vitro Activity Against Gram-negative Clinical Isolates Collected in Europe: Results from 3 SIDERO-WT surveillance studies during 2014-2016
    3 ECCMID 2019.
  • Cefiderocol in vitro Activity Against Gram-negative Clinical Isolates Collected in Europe: Results from SIDERO-CR 2014/16
    6 Ito A, Nishikawa T., Masumoto S, et al.