Posted by Michael Wonder on 21 Feb 2017
The Medicines Company announces FDA filing acceptance of new drug application for intravenous antibiotic Carbavance (meropenem-vaborbactam)
21 February 2017 - The Medicines Company today announced that the U.S. FDA has accepted for priority review the Company’s new drug application filing for Carbavance (meropenem-vaborbactam) for the treatment of complicated urinary tract infections. The FDA does not currently plan to hold an advisory committee meeting to discuss the application.
The NDA filing is based on results from the pivotal Phase III TANGO 1 clinical trial in patients with a complicated urinary tract infection. As previously announced, the TANGO 1 trial met both FDA and EMA pre-specified primary endpoints. Carbavance also demonstrated statistical superiority over piperacillin-tazobactam with overall success in 98.4% of patients. Supporting the NDA are interim data from the ongoing TANGO 2 Phase III trial, which compares the safety, tolerability and efficacy of Carbavance with best available therapy in patients with selected serious infections due to confirmed or suspected carbapenem-resistant Enterobacteriaceae. The TANGO 2 trial is ongoing and the Company expects results to be available before the end of the third quarter of 2017.
