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Shionogi’s novel antibiotic trial data published in The Lancet

Data from APEKS-NP and CREDIBLE-CR studies published

Japanese pharma company Shionogi has announced the publication of two studies of its novel antibiotic Fetcroja (cefiderocol) in The Lancet Infectious Diseases journal.

The data comes from the APEKS-NP and CREDIBLE-CR studies, which both demonstrated the efficacy and safety of Fetcroja against certain difficult-to-treat Gram-negative bacterial infections.

This included nosocomial pneumonia (NP), bloodstream infections (BSI), sepsis and complicated urinary tract infections (cUTI).

The APEKS-NP study evaluated Fetcroja in severely ill patients with hospital-acquired, ventilator-associated or healthcare-associated pneumonia caused by a broad range of Gram-negative bacteria.

In this clinical trial, Fetcroja successfully met the primary endpoint of non-inferiority in all-cause mortality (ACM) at day 14, with 2.4% for the Fetcroja arm and 11.6% for the standard antibiotic arm.

The second study, CREDIBLE-CR, evaluated Fetcroja as a treatment for a diverse range of serious Carbapenem-resistant (CR) infections.

The results of the CREDIBLE-CR study provided descriptive evidence of efficacy and safety of Fetcroja in this patient population, with an observed mortality difference between treatment arms on the subset of patients with Acinetobacter spp. infections.

However, there was no mortality difference observed in patients with P.aeruginosa or Enterobacterales without Acinetobacter spp. co-infections.

The European Commission approved Fetcroja earlier this year, and it is the first treatment which protects against all Gram-negative pathogens considered to be of ‘critical priority’ by the World Health Organization.

The 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 launched in the UK in September, launching as a treatment of infections caused by aerobic Gram-negative bacteria in adult patients.

In the UK, over 5,000 deaths per year are attributed to antimicrobial resistance (AMR), with over 25,000 death 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.

Article by
Lucy Parsons

14th October 2020

From: Research



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