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Antibiotic Combo Ceftolozane/Tazobactam Seeks Regulatory Approval
A new drug application (NDA) has been submitted to the FDA for approval of the investigational antibiotic ceftolozane/tazobactam (Cubist Pharmaceuticals) for the treatment of complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs).
The NDA submission was based on positive data from pivotal phase III clinical trials in patients with cUTIs and cIAIs, which met primary endpoints that were agreed upon with the FDA.
In 2013, the FDA granted ceftolozane/tazobactam “fast track” status for the indications of cUTI and cIAI, as well as hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).
Ceftolozane/tazobactam, an antibiotic candidate being developed to treat certain Gram-negative infections, consists of ceftolozane (a cephalosporin that has demonstrated potent in vitro activity against Pseudomonas aeruginosa) with tazobactam (a well-established beta-lactamase inhibitor). The addition of tazobactam broadens coverage to include most extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli, Klebsiella pneumoniae, and other Enterobacteriaceae.
In pivotal phase III trials of ceftolozane/tazobactam versus levofloxacin in patients with cUTIs, and of ceftolozane/tazobactam in combination with metronidazole versus meropenen in patients with cIAIs, ceftolozane/tazobactam met its primary endpoints of statistical non-inferiority.
Highly adaptive pathogens that can develop resistance through several mechanisms, treatment-resistant Gram-negative bacteria are a serious global public health concern. Collectively, E. coli, K. pneumoniae, and P. aeruginosa account for 27% of all pathogens and 70% of all Gram-negative pathogens causing health care-associated infections.
Gram-negative bacteria are common causes of IAIs, UTIs, and nosocomial pneumonia, as well as bacteremia. E. coli is the most common cause of UTIs, and P. aeruginosa is the most common Gram-negative organism causing VABP. In addition, P. aeruginosa is the second most common cause of catheter-associated UTIs.
Source: Cubist Pharmaceuticals; April 21, 2014.