The Medicines Company announced that the Food and Drug Administration (FDA) has granted Fast Track designation to Carbavance (meropenem-vaborbactam) for the treatment of complicated urinary tract infections (cUTI).
Carbavance is currently being investigated in 2 ongoing TANGO (Targeting Antibiotic Non-susceptible Gram-negative Organisms) Phase 3 clinical trials. TANGO 1 is a randomized, controlled trial evaluating the safety, tolerability, and efficacy of Carbavance vs. piperacillin/tazobactam in patients with cUTIs or acute pyelonephritis. Results are expected in the second half of 2016. TANGO 2 is evaluating the safety, tolerability, and efficacy of Carbavance compared to the best available antibiotic therapy in patients with serious infections (eg, cUTI, nosocomial pneumonia and/or bacteremia) due to confirmed or suspected CRE.
The FDA previously granted Carbavance Qualified Infectious Disease Product (QIDP) designation for cUTIs, intra-abdominal infections, HABP/VABP, and febrile neutropenia in 2014.
Carbavance, the combination of meropenem (carbapenem antibiotic) and vaborbactam (novel beta-lactamase inhibitor), is an investigational agent being developed for the treatment of gram-negative infections, including those due to carbapenem-resistant Enterobacteriaceae (CRE).
For more information call (800) 388-1189 or visit Themedicinescompany.com.