Shionogi’s cefiderocol approved in Australia
Japanese pharma major Shionogi (TYO: 4507) today announced that it has received marketing authorization 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 authorization is based on the results of three global clinical trials of cefiderocol conducted to date: the Phase II APEKS-cUTI study in patients with complicated urinary tract infections (cUTI), the Phase III CREDIBLE-CR study in patients with carbapenem-resistant Gram-negative bacterial infections, and the Phase III APEKS-NP study in patients with hospital-acquired pneumonia.
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