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30 Aug 2017

FDA approves new antibacterial drug

First carbapenem-based combination product – combination of meropenem with a new class of beta-lactamase inhibitor.

The Medicines Company has announced that the FDA has approved Vabomere (meropenem and vaborbactam) for injection for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, 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 inhibits certain types of resistance mechanisms used by bacteria.

Vabomere addresses gram-negative bacteria that produce beta-lactamase enzymes that have spread in the US 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 US and are classified by the US Centers for Disease Control (CDC) to be an urgent antimicrobial resistance threat. Vabomere was granted priority review and approval as a Qualified Infectious Disease Product (QIDP) in accordance with the Generating Antibiotics Incentives Now (GAIN) Act, which made Vabomere eligible for the FDA’s fast-track program, and approval now secures a 5-year regulatory extension of exclusivity under the Hatch-Waxman Act, which means that patent coverage and exclusivity in the US 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 (WHO).

“We are grateful to the FDA for working with us to advance the development and approval of Vabomere for cUTI on an accelerated basis to make this important treatment available to physicians and patients, who carry significant risks of death and mortality, at the soonest possible time,” said Clive Meanwell, CEO of The Medicines Company. “Vabomere represents a significant new advancement in addressing KPC-producing Enterobacteriaceae, for which there are currently limited treatment options. We look forward to a successful US launch of VABOMERE, leveraging our established, fully dedicated commercial infrastructure, and to expanding VABOMERE into other global markets.”

Cornelius Clancy Associate Professor in the Division of Infectious Diseases at University of Pittsburgh and Chief of Infectious Diseases at the VA Pittsburgh Health System commented: “Carbapenem antibiotics have been the preferred drugs for treating serious infections, such as cUTI, due to Enterobacteriaceae-producing, extended-spectrum beta-lactamases. With the dissemination of the KPC enzyme, new drugs that address this resistance mechanism to carbapenems are a welcome addition to our armamentarium.”

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. The trial enrolled 550 adult patients who were randomized 1:1 to receive Vabomere (meropenem 2g - vaborbactam 2g) as a 3-hour IV infusion every 8 hours, or piperacillin 4 g - tazobactam 500 mg as a 30-minute IV infusion every 8 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. Overall success was observed in 183/186 patients in the meropenem-vaborbactam group and in 165/175 patients in the piperacillin-tazobactam group – a difference of 4.1%. The most common adverse events for Vabomere included headache, infusion site reactions and diarrhea.

Michael Dudley, Senior Vice President, Head of R&D and Co-Leader for The Medicines Company’s Infectious Disease Business, noted: “We are grateful for the support of patients, families, and investigators that contributed to the rapid development of Vabomere as it progressed from discovery in our laboratories to availability for patients in under 8 years. This unprecedented speed has, in no small way, been due to our outstanding collaboration with, and support received from, the Biomedical Advanced Research and Development Authority (BARDA).”

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