Shionogi & Co has released new real-world evidence demonstrating the efficacy of its antibiotic, cefiderocol, against some of the most difficult-to-treat gram-negative bacterial infections.
The World Health Organization (WHO) has declared antimicrobial resistance (AMR) as one of the top ten threats to global health.
AMR occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medicines. As a result, infections become harder to treat and the risk of disease spread, severe illness and death increases.
PROVE – Retrospective Cefiderocol Chart Review – is an ongoing international, retrospective study of the real-world use of Shionogi’s cefiderocol for gram-negative infections across the EU and US.
The study includes nearly 200 patients with Pseudomonas aeruginosa infections. These were generally seriously ill patients, many requiring mechanical ventilation, vasopressor support or both.
Interim results, presented by the company at this year’s European Congress of Clinical Microbiology & Infectious Diseases, show that cefiderocol achieved clinical cure in 65% of these patients, and 81% were alive within 30 days of starting treatment.
Almost 100 patients with Acinetobacter baumannii infections were also included in the study. High levels of organ support were required in these patients, with 45% receiving mechanical ventilation and 30% requiring vasopressor support.
Cefiderocol achieved clinical cure in 60% of these patients, and 76% were alive within 30-days of starting treatment, Shionogi said.
Commenting on the positive results, Dominic Wichmann, consultant in the department of intensive care medicine, University of Hamburg-Eppendorf, said: “These interim results from PROVE build on a growing body of real-world evidence across Europe and the US demonstrating the efficacy of cefiderocol in treating patients with life-threatening infections, such as Acinetobacter baumannii and Pseudomonas aeruginosa, the majority of whom are very sick with multiple comorbidities.
“These are pathogens that fall into the WHO’s critical priority list, for which effective treatments are urgently needed.”
Cefiderocol is already available in Europe, under the brand name Fetcroja, to treat infections due to aerobic gram-negative organisms in adults with limited treatment options.
It is also indicated in the US, under the brand name Fetroja, to treat adults with hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and complicated urinary tract infections caused by certain susceptible gram-negative microorganisms.