The US Food and Drug Administration (FDA) has approved an antibacterial drug, Vabomere, for the treatment of adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria.
Antibacterial drug
Vabomere contains an antibacterial called meropenem as well as vaborbactam, which is an inhibitor that can help prevent bacterial resistance. The approval from the FDA of this drug has been based on the results of a clinical trial of more than 500 adults with cUTI, which demonstrated efficacy when compared with another antibacterial drug (piperacillin/tazobactam). However, the drug is associated with serious risks and as such must not be used in patients with a history of anaphylaxis.
“The FDA is committed to making new safe and effective antibacterial drugs available,” said Dr Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “This approval provides an additional treatment option for patients with cUTI, a type of serious bacterial infection.”
“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 Dr Clive Meanwell, PhD, chief executive officer 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.”
It has been recommended that Vabomere only be used in cases where the infection is suspected or proven to be caused by susceptible bacteria in order to minimise the risk of developing drug-resistant bacteria.
Approval of Vabomere has been granted to Rempex Pharmaceuticals, which was acquired by The Medicines Company in 2013.