Trials & Filings

Cubist Posts Topline Results from cIAI Trial

Antibiotic combo does well compared to meropenem

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Cubist Pharmaceuticals has posted positive top-line results from the pivotal Phase III trial of its antibiotic candidate ceftolozane/tazobactam in complicated intra-abdominal infections (cIAI). The treatment, in combination with metronidazole, met the FDA- and EMA-defined primary endpoints of statistical non-inferiority compared to meropenem. The primary endpoint was a clinical cure rate 26 to 30 days after the initiation of therapy (the Test of Cure visit). For the FDA, the primary analysis was...

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