Cubist Pharmaceuticals’ new drug application for its ceftolozane/tazobactam for treatment of complicated urinary tract infections and complicated intra-abdominal infections has been accepted by the US Food and Drug Administration (FDA) with priority review.
The company has submitted the new drug application for ceftolozane/tazobactam based on positive outcome from two pivotal Phase III clinical trials evaluating the antibiotic.
According to Cubist Pharmaceuticals, the two pivotal Phase III studies have met the FDA and the European Medicines Agency (EMA) specified primary endpoints. Results of the secondary analyses were consistent with and supportive of the primary outcomes.
The two studies demonstrated ceftolozane/tazobactam activity against problematic gram-negative bacteria, including Pseudomonas aeruginosa and extended-spectrum beta-lactamase-producing Escherichia coli and Klebsiella pneumoniae in population with complicated infections.
Cubist Pharmaceuticals chief scientific officer and research and development executive vice-president Steven Gilman said: "We look forward to working with the FDA on the review, and hope to bring this potential new treatment option to physicians and their patients to address resistant gram-negative infections."
The FDA has set a target action date of 21 December 2014 under the Prescription Drug User Fee Act for the new drug application.
The agency had designated ceftolozane/tazobactam as a Qualified Infectious Disease Product in 2013 for its potential indications of complicated urinary tract infections and complicated intra-abdominal infections.
Cubist Pharmaceuticals plans to submit a marketing authorisation application to the EMA during the second half of 2014 for its ceftolozane/tazobactam for the treatment of complicated urinary tract infections and complicated intra-abdominal infections.