Data from Pharmawand - Curated by EPG Health - Date added 24 September 2018

Melinta Therapeutics, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vabomere (meropenem and vaborbactam) for approval as a treatment for adult patients with complicated intra-abdominal (cIAI) and urinary tract infections (cUTI), hospital-acquired pneumonia including ventilator associated pneumonia (HAP/VAP), 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 (CRE)

Vabomere was approved by the FDA in August 2017 for the treatment of adult patients who have been diagnosed with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by treatment of adult patients caused by designated susceptible Enterobacteriaceae – Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which is a new class of beta-lactamase inhibitor that inhibits certain types of resistance mechanisms used by bacteria.

Comment: Melinta acquired the infectious diseases business of The Medicines Company in January 2018 which included three marketed products : Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin), and Minocin (minocycline) for Injection.

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Transplantation

Transplantation

See information on best practice in solid organ transplantation, and expert discussions on related hot topics.

Fluid Management

Fluid Management

Are you up-to-date with the latest evidence of effective procedures for fluid management?

+ 2 more

Allergic Rhinitis

Allergic Rhinitis

Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.

+ 4 more

Load more

Related Content