Singapore, Sept. 8 -- Japan-based Shionogi has received marketing authorisation from the Therapeutic Goods Administration (TGA) in Australia for cefiderocol, a siderophore cephalosporin developed by Shionogi for the treatment of carbapenem-resistant Gram-negative bacterial infections.

This marketing authorisation is based on the results of three global clinical trials of cefiderocol conducted to date: the Phase 2 APEKS-cUTI study in patients with complicated urinary tract infections (cUTI), the Phase 3 CREDIBLE-CR study in patients with carbapenem-resistant Gram-negative bacterial infections, and the Phase 3 APEKS-NP study in patients with hospital-acquired pneumonia.

The TGA has approved cefiderocol for the treatment of complicated uri...