1 April 2019 - Shionogi announces that the marketing authorisation application submission for cefiderocol, a novel siderophore cephalosporin, has been accepted for review by the EMA.
The CHMP has granted cefiderocol accelerated assessment indicating that this medication is expected to be of major public health interest, particularly from the point of view of therapeutic innovation. Shionogi is seeking an indication for the treatment of infections due to aerobic Gram-negative bacteria in adult patients with limited treatment options.
Cefiderocol is currently in clinical development. The APEKS-cUTI study was successfully completed in 2017.