MDCO's Carbavance meets in Phase III cUTI study

The Medicines Co. (NASDAQ:MDCO) said Carbavance meropenem/vaborbactam was non-inferior to tazobactam/piperacillin on both the FDA- and EMA-specified primary endpoints in the 550-patient, Phase III TANGO 1 trial to treat complicated urinary tract infection. The company plans to submit regulatory applications to EMA and FDA next year.

In TANGO 1's microbiologic modified intent-to-treat (mITT) population, Carbavance led to a clinical outcome rate of 98.4% vs. 94% for tazobactam piperacillin, meeting the FDA-specified primary endpoint of non-inferiority. The Medicines Co. said Carbavance also showed superiority to its comparator on the same endpoint, which was defined as cure or improvement and eradication at the end of IV treatment. Patients received either therapy every eight hours for up to 10 days. ...