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US FDA Approves The Medicines Company's Vabomere for Treatment of Complicated Urinary Tract Infections.

M2 PHARMA-August 31, 2017-US FDA Approves The Medicines Company's Vabomere for Treatment of Complicated Urinary Tract Infections

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- The US Food and Drug Administration has approved Vabomere (meropenem and vaborbactam) for injection for the treatment of adult patients with complicated urinary tract infections, including pyelonephritis, caused by designated susceptible Enterobacteriaceae Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex, US-based biopharmaceutical company The Medicines Company (NASDAQ: MDCO) said.

Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria. Vabomere addresses gram-negative bacteria that produce beta-lactamase enzymes that have spread in the United States and Europe, particularly the Klebsiella pneumoniae carbapenemase (KPC) enzyme.

KPC-producing bacteria are responsible for a large majority of all carbapenem-resistant Enterobacteriaceae in the United States and are classified by the US Centers for Disease Control to be an urgent antimicrobial resistance threat.

Vabomere was granted priority review and approval as a Qualified Infectious Disease Product in accordance with the Generating Antibiotics Incentives Now Act, which made Vabomere eligible for the FDA's fast-track programme, and approval now secures a five-year regulatory extension of exclusivity under the Hatch-Waxman Act, which means that patent coverage and exclusivity in the United States are expected to extend into 2031.

Vabomere was developed by The Medicines company's Infectious Disease Business and is a key addition to its leading portfolio of infectious disease products that provide broad treatment coverage for many of the highest-priority, drug-resistant pathogens identified by the CDC and the World Health Organization.

The FDA approval of Vabomere was supported by 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.

This trial enrolled 550 adult patients who were randomised 1: 1 to receive Vabomere (meropenem 2g - vaborbactam 2g) as a three-hour IV infusion every eight hours, or piperacillin 4g - tazobactam 500mg as a 30-minute IV infusion every eight hours, each for up to 10 days.

The primary assessment was performed in the microbiologic modified intent-to-treat (mMITT) patient population, and was defined as overall success of clinical outcome (cure or improvement) and microbiologic outcome of eradication (baseline bacterial pathogen reduced to < 104 CFU/ml).

Overall success was observed in 183/186 patients (98.4%) in the meropenem-vaborbactam group and in 165/175 patients (94.3%) in the piperacillin-tazobactam group a difference of 4.1% (95% CI: 0.3% to 8.8%).

The most common adverse events for Vabomere included headache, infusion site reactions and diarrhea.

Data from the TANGO clinical program, including data from 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, will be presented at IDWeek 2017, to be held October 4-8, 2017 in San Diego.

Last month, the company announced cessation of enrollment in TANGO-2 following a recommendation by the independent Data and Safety Monitoring Board, which concluded that a risk-benefit analysis of available data no longer supported randomization of additional patients to the "best available therapy" comparator arm.

Vabomere (meropenem and vaborbactam) is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex.

The meropenem component of Vabomere is a penem antibacterial drug. The bactericidal action of meropenem results from the inhibition of cell wall synthesis.

Meropenem penetrates the cell wall of most gram-positive and gram-negative bacteria to bind penicillin-binding protein targets. Meropenem is stable to hydrolysis by most beta-lactamases, including penicillinases and cephalosporinases produced by gram-negative and gram-positive bacteria, with the exception of carbapenem hydrolyzing beta-lactamases.

The vaborbactam component of Vabomere is a non-suicidal beta-lactamase inhibitor that protects meropenem from degradation by certain serine beta-lactamases such as Klebsiella pneumoniae carbapenemase. Vaborbactam does not have any antibacterial activity. Vaborbactam does not decrease the activity of meropenem against meropenem-susceptible organisms.

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Date:Aug 31, 2017
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