Osaka, Japan and FLORHAM PARK, New Jersey--(BUSINESS WIRE)--Shionogi & Co., Ltd. (hereinafter referred to as "Shionogi") announced today that it will share 11 abstracts of FETROJA® (cefiderocol) on IDWeek. The conference will be held on a virtual basis from September 29 to October 3, 2021.
President and CEO Dr. Akira Kato said: "The data provided on IDWeek underscores our commitment to combating antimicrobial resistance and the challenges faced in treating carbapenem-resistant Gram-negative bacteria. These challenges The high mortality rate is related to unmet needs." At Shionogi Inc. "We look forward to sharing new real-world data on FETROJA with the infectious disease community on IDWeek."
The presentation will include data from research sponsored by the company or sponsored by researchers. The abstract will be provided in the IDWeek interactive program, including:
For more information about FETROJA, please contact Shionogi at medinfo@shionogi.com.
About FETROJA® (cefiderocol) for injection FETROJA® (cefiderocol) is a cephalosporin antibiotic with a new mechanism for penetrating the cell membrane of Gram-negative pathogens in vitro as a siderophore. In addition to passive diffusion into the cell through the porin channel, FETROJA also binds to ferric iron and is actively transported into the bacterial cell through the outer membrane through the bacterial iron transporter. The function of the iron transporter is to absorb this essential nutrient for the bacteria. . These mechanisms allow FETROJA to reach high concentrations in the periplasmic space, where it can bind to penicillin binding proteins and inhibit cell wall synthesis in bacterial cells. FETROJA has also demonstrated in vitro activity against certain bacteria that contain very problematic resistant enzymes such as ESBL, AmpC, serine and metallocarbopenemase. Data from FETROJA multinational surveillance studies show that it has effective in vitro activity against a variety of gram-negative pathogens, including carbapenem-resistant Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter and maltophilia Spore bacteria. The clinical significance of in vitro data is unclear. FETROJA has poor in vitro activity against Gram-positive bacteria or anaerobic bacteria.
Cefiderocol is brand name FETCROJA® and has been approved by the European Commission for the treatment of infections caused by aerobic gram-negative bacteria in adults 18 years of age or older with limited treatment options.
American indications Fetroja® (cefiderocol) is suitable for patients 18 years of age or older to treat complicated urinary tract infections (cUTI), including pyelonephritis caused by the following sensitive gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, and strange Proteus, Pseudomonas aeruginosa and Enterobacter cloacae complex.
Fetroja is suitable for patients 18 years of age or older. It is used to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by the following sensitive gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, cloacae Bacillus complex, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens.
Usage In order to reduce the development of resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should only be used to treat or prevent infections that have been confirmed or strongly suspected of being caused by sensitive bacteria.
Contraindications Fetroja is contraindicated in patients who are known to have a history of severe hypersensitivity to cefdicol or other β-lactam antibacterials or any other ingredients of Fetroja.
The increase in all-cause mortality in patients with carbapenem-resistant gram-negative bacterial infections was observed in a cross-country, randomized, open-label trial. Compared with Best Available Therapy (BAT), all-cause mortality in patients treated with Fetroja Due to increased mortality, it is used for critically ill patients resistant to carbapenem gram-negative bacteria infection (NCT02714595). The trial included patients with hospital-acquired pneumonia, bloodstream infection, sepsis, or cUTI. The BAT regimen varies according to local practice and consists of 1 to 3 antibacterial drugs with activity against Gram-negative bacteria. Most BAT regimens contain colistin.
All-cause mortality increases in patients treated for hospital-acquired pneumonia, bloodstream infection, or sepsis. The 28-day all-cause mortality of patients treated with Fetroja was higher than that of patients treated with BAT [25/101 (24.8%) vs 9/49 (18.4%), treatment difference 6.4%, 95% CI (-8.6, 19.2) ]. By day 49, the all-cause mortality of patients treated with Fetroja was still higher than that of patients treated with BAT [34/101 (33.7%) vs 10/49 (20.4%), treatment difference 13.3%, 95% CI (- 2.5, 26.9) )]. Generally speaking, deaths are caused by gram-negative bacteria in patients with infections, including non-fermenting bacteria, such as Acinetobacter baumannii complex, Streptomonas maltophilia, and Pseudomonas aeruginosa, and the worsening of the infection Or the result of complications or potential comorbidities. The reason for the increase in mortality has not yet been determined.
Closely monitor the clinical response of patients with cUTI and HABP/VABP to treatment.
For complete U.S. prescription information, please visit Shionogi.com
Shionogi is committed to fighting antimicrobial resistance Shionogi has a deep foundation in the field of anti-infection, and has been committed to the development of antimicrobial therapies for more than 60 years. Shionogi is honored to be one of the few large pharmaceutical companies that continue to focus on the research and development of anti-infective drugs. Compared with other large pharmaceutical companies, the company has the highest proportion of pharmaceutical revenue in the research and development of related anti-infective drugs. 1
For more information, please refer to: https://www.shionogi.com/global/en/sustainability/amr.html
About Shionogi Shionogi & Co., Ltd. is a large-scale research-driven pharmaceutical company in Japan. Based on the corporate philosophy of "providing the best medicines and protecting the health and well-being of the patients we serve", Shionogi & Co., Ltd. is committed to benefiting patients. The company currently sells products in multiple therapeutic areas, including anti-infectives, pain, cardiovascular disease, and gastroenterology. Our pipeline focuses on infectious diseases, pain, central nervous system and oncology. For more information about Shionogi Co., Ltd., please visit https://www.shionogi.com/global/en/. Shionogi Inc. is an American subsidiary of Shionogi & Co., Ltd. located in New Jersey. For more information about Shionogi Inc., please visit www.shionogi.com.
Forward-looking statements This announcement contains forward-looking statements. These statements are based on the expectations of currently available information and assumptions that are affected by risks and uncertainties, which may cause actual results to differ materially from these statements. Risks and uncertainties include general economic conditions at home and abroad such as general industry and market conditions, as well as changes in interest rates and currency exchange rates. These risks and uncertainties especially apply to forward-looking statements related to the product. Product risks and uncertainties include, but are not limited to, the completion and termination of clinical trials; obtaining regulatory approval; statements and concerns regarding product safety and effectiveness; technological progress; adverse results of major litigation; domestic and foreign medical reforms and legal regulations Variety. In addition, for existing products, there are manufacturing and marketing risks, including but not limited to the inability to establish production capacity to meet demand, the unavailability of raw materials, and the entry of competing products. The company assumes no intention or obligation to update or revise any forward-looking statements due to new information, future events or other reasons.
https://accesstomedicinefoundation.org/media/uploads/downloads/5f3f76733efaa_Antimicrobial_Resistance_Benchmark_2020.pdf Last accessed in September 2021.
Lindsay Bohlander, Senior Director of Corporate Planning and Communication +1 973-307-3718 Lindsay.Bohlander@shionogi.com
Shionogi announced today that 11 abstracts on FETROJA® (cefiderocol) will be shared on IDWeek.
Lindsay Bohlander, Senior Director of Corporate Planning and Communication +1 973-307-3718 Lindsay.Bohlander@shionogi.com