FDA approves cUTI combo from MDCO

After market close Tuesday, FDA said it approved Vabomere meropenem/vaborbactam from The Medicines Co. (NASDAQ:MDCO) to treat adults with complicated urinary tract infections (cUTI) including pyelonephritis caused by Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex. The company plans to launch the drug and provide pricing information next quarter.

FDA based its approval on the Phase III TANGO-1 trial, in which Vabomere showed non-inferiority to tazobactam/piperacillin on both the FDA- and EMA-specified primary endpoints. The NDA was under Priority Review (see BioCentury Extra, June 27, 2016)...