dm+d

Unassigned

New Medicines

Vaborem (EU), Vabomere (US) Serious bacterial infections due to gram-ve bacteria

Information

Vaborem (EU), Vabomere (US)
New molecular entity
Menarini
Melinta Therapeutics

Development and Regulatory status

Launched
Launched
Launched
November 2019
Nov 19Launched in the UK. Pack size 6 Vials, price £334.00 [17].
Jun 19Menarini plans to launch in the UK in early 2020, possibly even December 19 [16].
Apr 19Vabomere has been available in the US since before Nov 17 [15].
Dec 18Approved in EU [13].
Sep 18Recommended for EU approval by CHMP - the full indication is "for the treatment of the following infections in adults: complicated urinary tract infection (cUTI), including pyelonephritis; complicated intra-abdominal infection (cIAI); hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of these infections. It is also indicated for the treatment of infections due to aerobic Gram -ve organisms in adults with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents." [12].
Jan 18Melinta Therapeutics acquired Meropenem/Vaborbactam from The Medicines Company [11].
Nov 17The Medicines Company has entered into an agreement to sell its antibiotics, Vabomere, Orbactiv and Minocin IV, to Melinta Therapeutics Inc. The transaction is expected to close Q1 2018 [10].
Aug 17Approved in US for adults with complicated urinary tract infections (cUTI) [9].
Jul 17Filed in EU via centralised procedure [8].
Feb 17FDA accepts filing of NDA for priority review carbavance injection for the treatment of complicated UTIs [5].
Jun 16Medicines Company expects to submit an NDA early 2017 to the FDA. The company anticipates that the data they have should be sufficient for submission to both the FDA and the EMA, since it met each of their pre-specified endpoints in complicated urinary tract infections (cUTI). It expects an EMA submission for this indication will also come in 2017 [4].
Apr 16FDA grant Fast Track Designation[3].
Nov 14In January 2014, the U.S. Food and Drug Administration (FDA) designated CARBAVANCE as a Qualified Infectious Disease Product (QIDP) [1].

Category

Meropenem, combined with RPX7009, a novel class of beta-lactamase inhibitor.
Serious bacterial infections due to gram-ve bacteria
Intravenous

Trial or other data

Oct 18Menarini Pharmaceuticals agrees exclusive rights with Melinta to commercialise and co-develop Vabomere, Orbactive and Minocin injections in Europe, Asia-Pacific countries (ex. Japan) and the Commonwealth of Independent States [14].
Oct 17Pooled analysis from the TANGO 1 and TANGO 2 trials were released by The Medicines Company. Pooled analysis from the two phase III TANGO 1 and TANGO 2 trials for meropenem/vaborbactam showed that mortality at 28 days was 25% in treatment-arm vs. 44% for best available therapy (43.7% reduction). In pts with complicated UTI/acute pyelonephritis (cUTI/AP), the overall success at the end-of-therapy was 72.7% in treatment-arm compared to 50% for best-available therapy; success at test-of-cure was 42.9% versus 50% for treatment-arm and best-available-therapy, respectively.[11].
Jul 17Company announces that randomisation in the TANGO-2 trial has been stopped early following recommendation of the independent Data and Safety Monitoring Board, based on an interim analysis of data from 72 patients. This risk-benefit analysis no longer supported randomisation of patients to the comparator arm of the trial (best available therapy). Enrolment to an amended single-arm study continues and the Company expects to publish data in the future. It has also announced that the trade name Vabomere has been approved by EU and US regulators [7].
Jun 16The Medicines Company announce top-line pivotal data from a trial treating patients with complicated urinary tract infections (cUTI) that demonstrated superiority compared with piperacillin-tazobactam. Patients were treated with a three-hour IV infusion given every 8 hours or piperacillin-tazobactam as a 30 minute IV infusion every 8 hours, with each given for up to 10 days. After at least 5 days of therapy, patients were transitioned to oral levofloxacin once they met predefined criteria [4].
Nov 14TANGO 2 is a is a PIII multi-Centre, randomized, open-label study of Carbavance (meropenem/RPX7009) Vs. “Best Available Therapy” in pts with selected serious infections due to carbapenem-resistant enterobacteriaceae. Approx. 150 pts with cUTI, nosocomial pneumonia and/or bacteraemia will be randomly assigned (2:1) to CARBAVANCE IV or “Best Available Therapy” for up to 14 days. Results from both CARBAVANCE Phase 3 trials are expected in 2016. [1]
Nov 14TANGO 1 is a PIII multi-Centre, randomized, double-blind, double-dummy study to evaluate the efficacy, safety, and tolerability of Carbavance (meropenem/RPX7009) compared to (Tazocin; piperacillin/tazobactam) in treating complicated UTI’s, including acute Pyelonephritis, in adults. Approximately 850 study subjects will be randomly assigned (1:1) to receive either CARBAVANCE IV or piperacillin/tazobactam IV for up to 10 days. Subjects in both arms who meet protocol defined criteria of improvement can be switched to oral levofloxacin after a minimum of 5 days of IV therapy. Results from both CARBAVANCE Phase 3 trials are expected in 2016. [1]

Evidence based evaluations