Cubist Pharma files ceftolozane/tazobactam at EMA for Urinary Tract and Intra Abdominal Infections.
Cubist Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has accepted for review the Company's Marketing Authorization Application (MAA) for its investigational antibiotic ceftolozane/tazobactam (CXA 201). Cubist is seeking approval of ceftolozane/tazobactam for the treatment of Complicated Urinary Tract Infections (cUTI)and Complicated Intra-Abdominal Infections (cIAI), with a decision from the European Commission (EC) expected during the second half of 2015.
The MAA submission is based on positive data from two pivotal Phase III clinical trials of ceftolozane/tazobactam in Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI). These studies met both the EMA and FDA specified primary endpoints. Results of the secondary analyses were consistent with and supportive of the primary outcomes. In the clinical trials, ceftolozane/tazobactam demonstrated activity against problematic Gram-negative bacteria, including Pseudomonas aeruginosa and extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli) and Klebsiella pneumoniae in patients with complicated infections.
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