Shionogi & Co., Ltd. announced that cefiderocol (S-649266), a novel siderophore cephalosporin in late-stage development, met the FDA pre-specified primary endpoint for non-inferiority vs imipenem/cilastatin (IPM/CS) in patients with serious complicated urinary tract infection (cUTI) with Gram-negative bacteria. Cefiderocol was superior to IPM/CS at test of cure (TOC). The study APEKs-cUTI enrolled 452 patients with cUTI. The median duration of treatment was nine days for both cefiderocol and IPM/CS for all populations. Cefiderocol met the FDA primary efficacy endpoint of composite of clinical cure and microbiologic eradication at test of cure (TOC) in 72.6% of patients (n=252) which was superior to IPM/CS at 54.6% (n=119), a weighted difference of 18.58% (95% CI: 8.23, 28.92). Cefiderocol was well tolerated in the study, with 40% of patients experiencing an adverse event in the cefiderocol arm vs 50% of patients in the IPM/CS arm. Serious adverse events (SAEs) occurred in 14 patients (4.7%) who received cefiderocol and 12 patients (8.1%) who received IPM/CS. Shionogi plans to submit an NDA for cefiderocol to the FDA in 2017. The data from the APEKs-cUTI clinical study are planned to be presented in early 2017.