FDA accepts Cubist’s ceftolozane/tazobactam NDA with Priority Review

The US Food and Drug Administration has accepted Cubist Pharmaceuticals’ (Nasdaq: CBST) New Drug Application for its investigational antibiotic ceftolozane/tazobactam with Priority Review.

Cubist is seeking FDA approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 21, 2014.

The NDA is based on positive data from two pivotal Phase III clinical trials of ceftolozane/tazobactam in complicated urinary tract infections and complicated intra-abdominal infections. These studies met both the FDA and the European Medicines Agency 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 and Klebsiella pneumoniae in patients with complicated infections.