A new antibacterial medication that combines meropenem and vaborbactam (Vabomere, The Medicines Company) has received FDA approval for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Meropenem is an antibacterial, while vaborbactam 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 Centers for Disease Control and Prevention as an urgent antimicrobial resistance threat. Bacteria designated as susceptible to Vabomere include Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex.
“Carbapenem antibiotics have been the preferred drugs for treating serious infections, such as cUTI, due to Enterobacteriaceae-producing, extended-spectrum beta-lactamases,” said Cornelius Clancy, MD, Associate Professor in the Division of Infectious Diseases at University of Pittsburgh and Chief of Infectious Diseases at the VA Pittsburgh Health System. “With the dissemination of the KPC enzyme, new drugs that address this resistance mechanism to carbapenems are a welcome addition to our armamentarium.”
The safety and efficacy of meropenem/vaborbactam were evaluated in a clinical trial with 545 adults with cUTI, including those with pyelonephritis. At the end of intravenous treatment with meropenem/vaborbactam, approximately 98% of patients treated with meropenem/vaborbactam compared with approximately 94% of patients treated with piperacillin/tazobactam, another antibacterial drug, had cure/improvement in symptoms and a negative urine culture test.
Approximately seven days after completing treatment, approximately 77% of patients treated with meropenem/vaborbactam compared with approximately 73% of patients treated with piperacillin/tazobactam had resolved symptoms and a negative urine culture.
The most common adverse reactions in patients taking meropenem/vaborbactam were headache, infusion site reactions, and diarrhea. Meropenem/vaborbactam is associated with serious risks, including allergic reactions and seizures. It should not be used in patients with a history of anaphylaxis, a type of severe allergic reaction to products in the class of beta-lactams.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of antibacterial drugs, meropenem/vaborbactam should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Vabomere was designated as a qualified infectious disease product, a designation given to antibacterial products that treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of this designation, Vabomere received a priority review.
The approval was granted in the name of Rempex Pharmaceuticals, Inc., which The Medicines Company acquired in December 2013.