Approval for Fetroja in South Korea

Japanese drug major Shionogi (TYO: 4507) announced that Jeil Pharmaceutical, its partner in South Korea, has obtained marketing approval from the domestic authorities for the gram-negative bacterial infection treatment Fetroja (cefiderocol).

Cefiderocol, an innovative siderophore cephalosporin, is authorized for the treatment of critically ill patients with carbapenem-resistant (CR) Gram-negative (GN) bacterial infections. In South Korea, the approval was based on the results of three global clinical trials (a Phase II trial [APEKS-cUTI] in patients with complicated urinary tract infections, a Phase III trial in patients with carbapenem-resistant gram-negative bacterial infections [CREDIBLE-CR], and a Phase III trial in patients with nosocomial pneumonia [APEKS-NP]).

“The brand name Fetroja embodies the concept of a 'Trojan Horse,’ as the drug penetrates bacterial cells through iron porin channels to defeat pathogens,” a Jeil official said, adding that “it will serve as a critical treatment option for patients suffering from complicated urinary tract infections and ventilator-associated pneumonia caused by MDR bacteria.”