APEKS-NP

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 .

FDA Accepts Shionogi’s Supplemental New Drug Application with Priority Review for FETROJA® (cefiderocol) for the Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

Retrieved on: 
Monday, June 1, 2020
FDA, Health, Hospitals, Clinical trials, Pharmaceutical, Biotechnology, Medical specialties, Medicine, Infectious diseases, Health, Bacterial diseases, Hospital-acquired pneumonia, Hospital-acquired infection, Bacterial pneumonia, Pneumonia, Bacteremia, Carbapenem, Linezolid, APEKS-NP, FETROJA® (cefiderocol) for injection, Shionogi

Shionogi submitted the sNDA for FETROJA for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative pathogens.

Key Points: 
  • Shionogi submitted the sNDA for FETROJA for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative pathogens.
  • Safety was investigated up to 28 days after the end of treatment unless there was an ongoing serious adverse event(s).
  • The safety and efficacy of FETROJA have not been established for the treatment of nosocomial pneumonia, bloodstream infections or sepsis.
  • Reserve FETROJA for use in patients who have limited or no alternative treatment options for the treatment of cUTI.

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.