Cubist Pharma files new drug application with USFDA for ceftolozane/tazobactam

23rd April 2014 (Last Updated April 23rd, 2014 01:00)

Cubist Pharmaceuticals has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for its investigational antibiotic, ceftolozane/tazobactam for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

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Cubist Pharmaceuticals has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for its investigational antibiotic, ceftolozane/tazobactam for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

The ceftolozane/tazobactam is an antibiotic candidate is being developed for the treatment of certain Gram-negative infections.

The NDA submission is based on positive results from its pivotal Phase III clinical trials in cUTI and cIAI.

Ceftolozane/tazobactam, in combination with metronidazole, was studied against meropenen, ceftolozane/tazobactam in cIAI in a pivotal Phase III clinical trial and against levofloxacin in cUTI in a pivotal Phase III clinical trial.

Ceftolozane/tazobactam met the primary endpoints of statistical non-inferiority in the Phase III studies, while results of the secondary analyses were consistent with and supportive of the primary outcomes.

Cubist Pharmaceuticals chief scientific officer and R&D executive vice-president Dr Steven Gilman noted that 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," Dr Gilman said.

In 2013, ceftolozane/tazobactam received fast-track status from the FDA for its qualified infectious disease product (QIDP) indications of cUTI and cIAI, as well as hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP).

"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."

Cubist Pharmaceuticals is currently planning to file marketing authorisation application with the European Medicines Agency for ceftolozane/tazobactam in the cUTI and cIAI indications during the second half of 2014.

The company is also in the process of initiating investigational sites for a pivotal Phase III clinical study of ceftolozane/tazobactam in HABP/ VABP.

Ceftolozane/tazobactam is a novel, antipseudomonal cephalosporin and a well-established ß-lactamase inhibitor. It has shown potent in-vitro activity against Pseudomonas aeruginosa.

By inhibiting essential penicillin-binding proteins, Ceftolozane exerts its bactericidal activity that leads to the inhibition of cell-wall synthesis and subsequent cell death.

An inhibitor of most class A ß-lactamases and some class C ß-lactamases, tazobactam protects ceftolozane from hydrolysis and broadens coverage to include most extended-spectrum ß-lactamase-(ESBL) producing Enterobacteriaceae.

Ceftolozane/tazobactam has shown activity against Escherichia coli and Klebsiella pneumoniae, including strains producing ESBL enzymes.


Image: Ball-and-stick model of tazobactam molecule. Photo: courtesy of MarinaVladivostok.