The Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) of Carbavance (meropenem-vaborbactam; The Medicines Company) for the treatment of complicated urinary tract infections (cUTIs).
The NDA submission was supported by data from TANGO 1, a Phase 3 clinical trial evaluating Carbavance in patients with cUTIs. The study met the pre-specified primary endpoints and showed that treatment with Carbavance is associated with an overall success rate of 98.4%, demonstrating statistical superiority over piperacillin-tazobactam.
Additional interim data from TANGO 2, an ongoing Phase 3 study comparing the safety, tolerability and efficacy of Carbavance with best available antibiotics in patients with carbapenem-resistant Enterobacteriaceae (CRE) infections, also supported the NDA.
Carbavance is an investigational injectable antibiotic combining the carbapenem, meropenem, and the novel beta-lactamase inhibitor, vaborbactam (RPX7009), for the potential treatment of serious gram-negative infections, including those caused by CRE.
For more information call (800) 388-1189 or visit TheMedicinesCompany.com.