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MEROPENEM/VABORBACTAM

Carbapenem antibiotic

ANTI-INFETCTIVE

CURRENT DEVELOPMENT PHASE: CRE Infections/Carbapenem resistant Enterobacteriaceae

preclinicl
phase i
phase ii
phase iii
registration
post-registration

Meropenem / Vaborbactam is a new carbapenem antibiotic for systemic use that has received in November 2018 the Marketing Authorisation (MA) from the European Commission for the treatment of complicated urinary tract infections (cUTI) including acute pyelonephritis, complicated intra-abdominal infections (cIAI) and hospital-acquired pneumonia (HAP), such as ventilator associated pneumonia (VAP).

Meropenem/Vaborbactam is the first combination of a carbapenem and a beta-lactamase inhibitor with a microbial spectrum covering the Carbapenamase-producing Enterobacteriaceae, responding to a huge unmet medical need identified as Priority 1 by the WHO. MA relied on the results of 2 clinical studies, one of these TANGO II, where the combination has been compared with the “best available treatment”. The treatment was associated with increased clinical cure and reduced mortality. The increased cure rate was statistically significant also in immunocompromised patients, a group usually excluded from clinical trials.

Meropenem/Vaborbactam appears to be a potential game changer in the fight against difficult-to-treat Gram negative infections, satisfying an important medical need linked to antibiotic-resistant Enterobacteriaceae. Extensive studies are ongoing to assess the possible application of this product to the pediatric population.

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