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Shionogi Eyes ’17 US Cefiderocol Filing After New Results

 
• By Ian Haydock

Shionogi's novel antibiotic cefiderocol has met its primary endpoint in a pivotal clinical trial, clearing the way for a US approval filing this year for what will be a strategically important product for the Japanese company.

Antibiotic resistant bacteria closeup biofilm

Shionogi & Co. Ltd.'s novel antibiotic cefiderocol (S-649266) is on track for a US NDA submission for complicated urinary tract infections (cUTI) sometime this year following promising top-line results in a pivotal registrational study.

The siderophore cephalosporin met its primary endpoint of non-inferiority to imipenem/cilastatin in the patients with serious Gram-negative bacterial cUTI, and...

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