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Shionogi's Gram-negative antibiotic launches in the UK

Novel antibiotic is indicated for use against Gram-negative bacterial infections

Shionogi’s new antibiotic Fetcroja is now available for use in the UK for the treatment of infections caused by aerobic Gram-negative bacteria in adults.

The launch of Shionogi's Fetcroja (cefiderocol) in the UK is its first after the drug gained European Commission approval earlier this year, and is the first treatment which protects against all Gram-negative pathogens considered to be of 'critical priority' by the World Health Organization.

This includes carbapenem-resistant strains of Enterobacterales, P. aeruginosa and A. baumannii, all of which have been highlighted as the top priority in the research and development of new antibiotics.

Shionogi’s novel antibiotic is designed to use the bacteria’s own iron uptake system to gain entry into the cell and inhibit cell wall synthesis.

“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,” said Jonathon Osborne, General Manager of Shionogi UK.

The use of Fectroja in a range of infections is supported by data from three clinical studies, APEKS-cUTI, APEKS-NP, and CREDIBLE-CR. In these studies, the drug demonstrated efficacy against complicated urinary tract infections (cUTI), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) and blood stream infections (BSI).

In the UK, over 5,000 deaths per year are attributed to antimicrobial resistance (AMR), with over 25,000 deaths per year attributed to AMR in the EU. AMR is a major health burden wherein bacteria, fungi, viruses and parasites become resistant to a range of antimicrobial drugs, such as antibiotics, antifungals and antivirals.

In the US, Shionogi’s drug is approved under the name Fetroja for the treatment of adult patients with cUTI who have limited or no alternative treatment options.

The US Food and Drug Administration (FDA) approval of Fetroja was based on results from the APEKS-cUTI study, in which the novel antibiotic demonstrated significantly higher response rates compared to the older antibiotic imipenem/cilastatin.

In July, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) raised nearly $1bn to support clinical research into new antibiotics in an effort to tackle AMR.

By 2050 experts predict that, each year, antibiotic resistance could result in the deaths of ten million people worldwide if no action is taken, resulting in a drop in global economic output of $100 trillion.

The AMR Action Fund was created to bring two to four new antibiotics to patients by 2030, a collaborative effort made possible by the IFPMA, along with the European Investment Bank (EIB), Wellcome Trust and the World Health Organization (WHO).

“Investment to ensure promising antibacterial treatments successfully move through to market is a critical step in tackling AMR,” said Haileyesus Getahun, director of the Department of Global Coordination and Partnership on AMR at WHO.

“WHO stands ready to support the AMR Action Fund in its focus on public health priorities and innovative new antibacterial treatments,” she added.

Article by
Lucy Parsons

16th September 2020

From: Regulatory



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