MDCO's Carbavance gets Priority Review

The Medicines Co. (NASDAQ:MDCO) said FDA accepted and granted Priority Review to an NDA for IV Carbavance meropenem/vaborbactam to treat complicated urinary tract infections (cUTIs). The company did not disclose the PDUFA date, but said FDA does not plan to hold an advisory committee meeting to discuss the NDA.

Last year, Carbavance showed non-inferiority to tazobactam/piperacillin on both the FDA- and EMA-specified primary endpoints in the Phase III TANGO 1 trial to treat cUTI (see BioCentury Extra, June 27, 2016)...