EC approves Shionogi's new antibiotic Fetcroja

Shionogi’s new antibiotic, Fetcroja (cefiderocol), is now approved in Europe for the treatment of infections due to aerobic Gram-negative bacteria in adults with limited treatment options.

The drug is the first to provide coverage against all Gram-negative pathogens considered of critical priority by the World Health Organisation – carbapenem-resistant Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacteriaceae.

It is also the world’s first siderophore cephalosporin that uses the bacteria’s own iron uptake system to gain entry into the cell, acting like a Trojan horse, according to a spokesperson or the firm.

Data from three clinical studies – APEKS-cUTI and APEKS-NP and CREDIBLE-CR – demonstrated the efficacy of cefiderocol in patients with the following types of infection: complicated urinary tract infections, hospital-acquired pneumonia, ventilator-associated pneumonia, sepsis and patients with bacteraemia.

One of the studies included patients with Gram-negative infections caused by multidrug-resistant pathogens including carbapenem-resistant bacteria from the WHO priority list, Shionogi noted.

There is an urgent need for new to fight the growing crisis of antimicrobial resistance; in Europe 25,000 people die each year multidrug-resistant bacterial infections, and this number could reach 10 million globally by 2050.

“Antimicrobial resistance is a growing global health threat that is only set to get worse if no action is taken, so it is very welcome news that this new and effective antibiotic has now been approved in Europe, commented Professor Peter Hawkey, Institute of Microbiology and Infection College of Medical and Dental Sciences, University of Birmingham.

“Cefiderocol is active against all the critical pathogens that are most concerning to the World Health Organisation so will be a much-needed option for clinicians treating some of the most severe Gram-negative infections.”

28th April 2020

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