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news.The European Medicines Agency (EMA) has accepted review of US-based Cubist Pharmaceuticals' marketing authorization application (MAA) for its investigational antibiotic ceftolozane/tazobactam to treat complicated urinary tract Infections and complicated intra-abdominal infections.
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A decision from the European Commission (EC) regarding the approval of ceftolozane/tazobactam is expected during the second half of 2015
The marketing application is based on positive data from two pivotal Phase III clinical trials of ceftolozane/tazobactam carried out in patients with complicated urinary tract infections and intra-abdominal infections.
The two trials met both the EMA and US Food and Drug Administration (FDA) specified primary endpoints.
According to the company, results of the secondary analyses were consistent with and supportive of the primary outcomes.
In these trials, ceftolozane/tazobactam showed activity against problematic Gram-negative bacteria, including Pseudomonas aeruginosa and extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli) and Klebsiella pneumoniae in patients with complicated infections.
Cubist executive vice president of Research and Development and chief scientific officer Steven Gilman said the company is happy to receive MAA acceptance for ceftolozane/tazobactam and look forward to working with the EMA on this important review.
"As we continue to expand globally, this advancement further positions Cubist to respond to growing health threats and reinforces our commitment to bring new antibiotics to patients worldwide facing serious infections, including those caused by Gram-negative bacteria," Gilman said.
The US FDA has already accepted the company’s new drug application (NDA) for ceftolozane/tazobactam with priority review and assigned an action date of 21 December 2014.