The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submission for cefiderocol from Shionogi (TYO: 4507).
The Japanese pharma major is seeking an indication for the treatment of infections due to aerobic Gram-negative bacteria in adult patients with limited treatment options.
Cefiderocol has been granted accelerated assessment, having shown in vitro activity against all the Gram-negative species that were identified by the World Health Organization as being the highest priority for finding new treatments.
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