Research & Development
US FDA grants approval to Shionogi's Fetroja
18 November 2019 -

The US Food and Drug Administration (FDA) has granted approval to Japan-based Shionogi for its Fetroja (cefiderocol) intended to treat complicated urinary tract infections (cUTI) in adult patients with limited or no alternative treatment, it was reported on Friday.

The product has been approved to treat cUTI's, including pyelonephritis. It can be utilised to treat cUT caused by susceptible Gram-negative microorganisms such as Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex.

The product received approval based on data from the APEKS- complicated urinary tract infections study, which is a multinational, multicentre and double-blind clinical trial designed to assess the efficacy and safety of Fetroja against imipenem/cilastatin (IPM/CS) in patients with cUT's.