Shionogi & Co., Ltd. unveiled groundbreaking findings from the largest European real-world evidence study, PERSEUS, at the 34th ESCMID Global (formerly ECCMID) conference in Barcelona from April 27th to 30th, 2024. The study focused on Fetroja®/Fetcroja® (cefiderocol), a novel siderophore cephalosporin, in treating critically ill patients with carbapenem-resistant Gram-negative bacterial infections.
PERSEUS, a retrospective multicenter observational study, aimed to evaluate the effectiveness and safety of cefiderocol in adult patients with Gram-negative bacterial infections. Results indicated an impressive overall clinical success rate of 84.3% among patients receiving cefiderocol, with a 28-day all-cause mortality rate of 21.5%. The majority of patients suffered from respiratory tract infections, predominantly caused by Pseudomonas aeruginosa, Klebsiella pneumoniae, and Stenotrophomonas maltophilia. Notably, a significant proportion of patients had polymicrobial infections.
The study encompassed 261 critically ill adult patients in Spain who had limited treatment options and were administered cefiderocol for less than 28 days through Shionogi’s Early Access Program. Among them, a substantial portion showed resistance to all tested antibiotics, with almost half experiencing treatment failure with previous antibiotics. These patients, many of whom were in intensive care units and required mechanical ventilation or were in a state of septic shock, exhibited serious comorbidities such as immunosuppression, tumors, diabetes, and chronic renal or pulmonary diseases.
Overall, cefiderocol demonstrated good tolerability, with only six patients experiencing adverse drug reactions. Dr. Alex Soriano of Hospital Clinic in Barcelona emphasized the importance of real-world evidence in guiding antibiotic therapy for multidrug-resistant pathogens, particularly considering the challenges of conducting randomized clinical trials in such cases.
Isao Teshirogi, Ph.D., CEO of Shionogi, reiterated the company’s commitment to combatting antimicrobial resistance through innovative research. Cefiderocol, listed in the World Health Organization’s Model List of Essential Medicines, continues to play a crucial role in improving outcomes for patients with challenging infections.
Furthermore, Shionogi emphasized its dedication to ensuring global access to essential medicines like cefiderocol, collaborating with partners such as GARDP and CHAI to support availability in low- and middle-income countries.
Shionogi & Co., Ltd., a 146-year-old pharmaceutical company headquartered in Osaka, Japan, remains focused on its mission to provide the best possible medicines for patient health and well-being. With a strong heritage in anti-infectives, Shionogi continues its research and development efforts in infectious diseases and pain/CNS disorders.
For more information about Shionogi & Co., Ltd., visit https://www.shionogi.com/global/en.
Additionally, cefiderocol is available in Europe as Fetcroja® for treating infections caused by aerobic Gram-negative organisms in adults with limited treatment options. In the U.S., it is marketed as Fetroja® and indicated for treating hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and complicated urinary tract infections caused by certain susceptible Gram-negative microorganisms. In Japan, it is available as Fetroja®, approved for various infections caused by carbapenem-resistant strains of specified Gram-negative bacteria.
This announcement includes forward-looking statements based on current information and assumptions, subject to risks and uncertainties that could affect actual results. These risks include economic conditions, changes in industry and market conditions, regulatory approvals, product safety concerns, and manufacturing challenges. Shionogi disclaims any obligation to update or revise forward-looking statements based on new information or future events.
