Japanese pharma Shionogi has gained marketing authorisation from the European Commission for its antibiotic Fetcroja as a treatment for infections caused by gram-negative bacteria.

Fetcroja (cefiderocol) has been indicated for use in adults with limited treatment options, meaning the drug will be administered after treatment with standard antibiotics has failed to work.

The approval is a significant win for Shionogi, with this EU approval making Fetcroja the first antibiotic approved to cover against all gram-negative pathogens that are considered a priority by the World Health Organization (WHO).

In 2017, the WHO published a list of bacteria for which new antibiotics are urgently needed, after observing a worrying rise in infections that are resistant to standard treatments.

The list highlighted in particular the urgent issue of gram-negative bacteria, which are resistant to multiple antibiotics, and also have ‘built-in abilities’ to find new methods of resistance to treatment.

The EU approval was based on data from multinational surveillance studies of Fetcroja which demonstrated significant in vitro activity against a wide range of aerobic gram-negative pathogens, and also against certain bacteria that contain problematic resistant enzymes.

That data was also supported by further clinical data from three key studies of the antibiotic, including the APEKS-cUTI and APEKS-NP and CREDIBLE-CR studies. Fetcroja demonstrated efficacy in a number of infections across these studies, including complicated urinary tract infections (cUTI), hospital-acquired pneumonia (HAP), sepsis and more.

“This approval represents another significant milestone in Shionogi’s ongoing commitment to develop medicines that help fight these life-threatening infections in patients for whom limited, or no alternative treatment options exist,” said Takuko Sawada, Shionogi’s director of the board and executive vice president.

“Fectroja’s novel mechanism of cell entry is like a Trojan horse; it exploits the bacteria’s own iron uptake transporters to effectively enter the bacterial cell, which allows it to overcome the three major mechanisms of carbapenem-resistance in gram-negative bacteria,” he added.

Shionogi picked up an FDA approval for the antibiotic, under the US brand name of Fetroja, last November as a treatment for adults with complicated urinary tract infections (cUTI) who have limited or no alternative treatment options.

The Japanese pharma is one of just a few major drug developers still researching new antibiotics, as there is usually no significant payback for the cost of R&D in this area. This is due largely to the fact that the newest, most effective drugs are often kept in reserve and only used when infections do not respond to older agents.

As cases of resistant infections rise across the globe however, governments across the world are beginning to incentivise the development of new antibiotics to encourage pharma companies to reignite their efforts.