Meropenem/vaborbactam: Phase III data
Top-line data from 374 patients with cUTI or acute pyelonephritis in the microbiologic mITT population of the double-blind, double-dummy, international Phase III TANGO 1 trial showed that 2 g/2 g Carbavance meropenem/vaborbactam as a 3-hour IV infusion every 8 hours for up to 10 days met the FDA-specified primary endpoint of non-inferiority to tazobactam/piperacillin in overall success rate at the EOIVT visit (98.4% vs. 94%). Overall success was defined as a clinical outcome of cure or improvement and a reduction in baseline bacterial pathogen to <104 colony forming units (CFUs)/mL. The Medicines Co. also said Carbavance was superior to tazobactam/piperacillin on the FDA-specified endpoint. Additionally, Carbavance met the EMA-specified primary endpoints of non-inferiority to tazobactam/piperacillin in the proportion of patients with a reduction in baseline bacterial pathogen to <103 CFUs/mL at the TOC visit on days 15-23 in the microbiologic mITT population (66.7% vs. 57.7%) and the microbiologically evaluable population (n=347) (66.3% vs. 60.4%). The trial enrolled 550 patients. After >=5 days of treatment, patients who met protocol-defined criteria of improvement were transitioned to once-daily 500 mg oral levofloxacin. ...