Posted by Michael Wonder on 28 Nov 2018
Melinta Therapeutics granted European Commission marketing authorisation for Vabomere (meropenem with vaborbactam)
27 November 2018 - Melinta Therapeutics today announced that the European Commission has approved Vabomere (meropenem and vaborbactam) for use in adult patients with complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia including ventilator associated pneumonia, bacteraemia that occurs in association with any of these infections, and infections due to aerobic gram-negative organisms where treatment options are limited.
The EC approval follows a positive opinion issued by the CHMP of the EMA in September 2018, that was based in part on data from the TANGO clinical program.
TANGO-1, a Phase III, multi-center, randomized, double-blind, double-dummy study, evaluated the efficacy, safety and tolerability of Vabomere compared to piperacillin-tazobactam in the treatment of adults with cUTI, including acute pyelonephritis. TANGO-2, a multi-center, randomised, open-label clinical trial, assessed Vabomere versus “best available therapy” in adults with known or suspected carbapenem-resistant Enterobacteriaceae.
