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news.US-based Cubist Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval of its investigational antibiotic ceftolozane/tazobactam to treat Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI).
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The company is developing ceftolozane/tazobactam for the treatment of certain Gram-negative infections.
The NDA is based on positive data from pivotal Phase III clinical trials in cUTI and cIAI, which met primary endpoints that were agreed upon with the FDA and European Medicines Agency (EMA).
The company said that results of the secondary analyses were consistent with and supportive of the primary outcomes.
Cubist Pharmaceuticals executive vice president of R&D and chief scientific officer Steven Gilman said ceftolozane/tazobactam has been developed to target common and problematic Gram-negative pathogens resistant to current therapies and found in certain types of complicated infections.
"Our NDA submission for ceftolozane/tazobactam represents our focus at Cubist to fight global antimicrobial resistance, and offer potential novel treatment options to physicians for appropriate patients," Gilman said.
In the second half of 2014, the company intends to submit a Marketing Authorization Application (MAA) for ceftolozane/tazobactam to the EMA in the cUTI and cIAI indications.
In addition, the company is currently in the process of starting investigational sites for a major Phase III clinical trial of ceftolozane/tazobactam in HABP/ VABP.