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ARTICLE | Clinical News

Shionogi's cefiderocol passes Phase II cUTI test

January 13, 2017 12:16 AM UTC

Shionogi & Co. Ltd. (Tokyo:4507) said cefiderocol (S-649266) met FDA's pre-specified primary endpoint of the Phase II APEKs-cUTI study to treat complicated urinary tract infection with Gram-negative bacteria. The company said it plans to submit an NDA for the candidate this year.

Shionogi said cefiderocol was superior to imipenem and cilastatin therapy on the composite primary endpoint, which measured clinical cure and microbiologic eradication about seven days after treatment. Cefiderocol met the endpoint in 72.6% of patients vs. 54.6% for the comparator...

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