Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has accepted Cubist Pharmaceuticals' New Drug Application (NDA) for its investigational antibiotic ceftolozane/tazobactam with Priority Review.
Subscribe to our email newsletter
The ceftolozane/tazobactam is being developed to treat complicated urinary tract and intra-abdominal infections.
The submission of NDA is supported by the positive data from two pivotal Phase 3 clinical trials of ceftolozane/tazobactam.
The clinical trials showed ceftolozane/tazobactam activity against problematic Gram-negative bacteria, including Pseudomonas aeruginosa and extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli) and Klebsiella pneumoniae in population with complicated infections.
Cubist Research and Development executive vice president and chief scientific officer Steven Gilman said the hopes to bring this potential new treatment option to physicians and their patients to address resistant Gram-negative infections.
"This important milestone reinforces our global commitment to advance the development of antibiotics to combat serious public health threats," Gilman added.
In 2013, ceftolozane/tazobactam was designated as a Qualified Infectious Disease Product (QIDP) by the FDA for its potential indications of cUTI and cIAI.
Awarded according to the Generating Antibiotic Incentives Now (GAIN) Act, the QIDP designation for ceftolozane/tazobactam allows for certain incentives related to the development of new antibiotics.
The company is planning to submit a Marketing Authorization Application (MAA) to the EMA for ceftolozane/tazobactam, in the second half of 2014.