21 September 2018 - Recommended to be approved for treatment of patients with bacterial infection of various sites.

Melinta Therapeutics today announced that the CHMP of the EMA has adopted a positive opinion recommending Vabomere (meropenem and vaborbactam) for approval as a treatment for adult patients with complicated intra-abdominal and urinary tract infections (cUTI), 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 CHMP opinion was supported by data from the TANGO clinical program, including data from TANGO-1, a Phase III, multi-center, randomized, double-blind, double-dummy study to evaluate the efficacy, safety and tolerability of Vabomere compared to piperacillin-tazobactam in the treatment of cUTI, including acute pyelonephritis, in adults, as well as TANGO-2, a multi-center, randomized, open-label clinical trial of Vabomere versus “best available therapy” in subjects with known or suspected carbapenem-resistant Enterobacteriaceae.

Read Melinta Therapeutics press release