Cubist Pharmaceuticals Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of its investigational antibiotic ceftolozane/tazobactam for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). Ceftolozane/tazobactam is an antibiotic candidate being developed to treat certain Gram-negative infections. The NDA submission is based on positive data from pivotal Phase 3 clinical trials in cUTI and cIAI, which met primary endpoints that were agreed upon with the FDA and European Medicines Agency (EMA). Results of the secondary analyses were consistent with and supportive of the primary outcomes.
“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,” said Steven Gilman, executive vice president of research and development and chief scientific officer of Cubist Pharmaceuticals. “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.”
In 2013, the FDA granted ceftolozane/tazobactam Fast Track status for its Qualified Infectious Disease Product (QIDP) indications of cUTI and cIAI, as well as hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP). The QIDP designation for ceftolozane/tazobactam, enabled by the Generating Antibiotic Incentives Now (GAIN) Act, allows for certain incentives related to the development of new antibiotics, including eligibility for Fast Track status and Priority Review, and, if ceftolozane/tazobactam is ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity.
Cubist expects to submit a Marketing Authorization Application (MAA) for ceftolozane/tazobactam to the EMA in the cUTI and cIAI indications during the second half of 2014. Additionally, the company is currently in the process of initiating investigational sites for a pivotal Phase 3 clinical trial of ceftolozane/tazobactam in HABP/VABP.
Date: April 21, 2014
Source: Cubist Pharmaceuticals
