Cubist Submits NDA for Combination Antibiotic

Cubist announced that it has submitted a New Drug Application (NDA) to the FDA for its investigational antibiotic, ceftolozane/tazobactam for the treatment of Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI). Ceftolozane is a cephalosporin antibiotic; tazobactam is a β-lactamase inhibitor.

The NDA submission is based on positive data from pivotal Phase 3 clinical trials in cUTI and cIAI. The primary endpoints were met in the Phase 3 studies. Results of the secondary analyses were consistent with and supportive of the primary outcomes.

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Previously in 2013, the FDA granted ceftolozane/tazobactam Fast Track status for its Qualified Infectious Disease Product (QIDP) indications of cUTI and cIAI, as well as Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP). Cubist is currently in the process of initiating investigational sites for a pivotal Phase 3 clinical trial of ceftolozane/tazobactam in HABP/ VABP.

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