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).
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.