Japanese pharma company Shionogi has announced that its new antibiotic Fetcroja (cefiderocol) is now available for use in the UK, the first country to launch the drug following its European Commission (EC) approval earlier this year.
The drug is indicated for use as a treatment of infections caused by aerobic Gram-negative bacteria in adults aged 18 years or older with limited treatment options.
Fetcroja was approved by the EC based on nonclinical data and data from three clinical studies of the drug in complicated UTI, nosocomial pneumonia and critically ill patients with confirmed carbapenem-resistant infection.
Data from a range of multinational surveillance studies have shown that Fetcroja can produce potent in vitro activity against a broad spectrum of aerobic Gram-negative pathogens, including all three pathogens identified by the World Health Organization as being of a ‘critical priority’.
In addition to the surveillance studies, data from three clinical studies – APEKS-cUTI, APEKS-NP, and CREDIBLE-CR – also support the use of Fetcroja in patients with a number of different types of infection, including complicated urinary tract infections (cUTI), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), blood stream infections (BSI) including sepsis and patients with bacteraemia.
“We are delighted to announce the launch of Fetcroja in the UK, an important milestone which demonstrates Shionogi’s ongoing commitment to develop novel medicines in the fight against antimicrobial resistance,” said Jonathon Osborne, General Manager of Shionogi UK.
“Fetcroja can now be used to treat some of the most life-threatening infections in patients for whom there are limited or no alternative treatment options,” he added.
Antimicrobial resistance (AMR) is fast becoming a critical health issue across the globe, causing an increased need for new antibiotics to address the burden. In the EU, around 25,000 deaths per year are caused by an infection with multidrug-resistant bacteria, while in the UK over 5,000 deaths can be attributed to AMR.
According to experts, if no action is taken antibiotic resistance is predicated to kill ten million people every year globally by 2050, with a total cost to global economic output of $100 trillion.