Cubist's ceftolozane/ tazobactam accepted for Marketing Authorization Application review by EMA

The European Medicines Agency has accepted for review a Marketing Authorization Application by American biopharma company Cubist (Nasdaq: CBST) for its investigational antibiotic ceftolozane/tazobactam.

Cubist is seeking approval for the drug in the treatment of complicated urinary tract infections and complicated intra-abdominal infections. The European Commission is expected to make its decision in the second half of 2015.

Its submission is based on positive data from  two Phase III studies in both these indications. They both met their primary endpoints, as specified by the EMA and the US Food and Drug Administration. Secondary analyses were consistent with the primary outcomes. The drug demonstrated activity against gram-negative bacteria.