The US Food and Drug Administration has approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria.
Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.
‘The FDA is committed to making new safe and effective antibacterial drugs available,’ explained Edward Cox, MD, Director of the Office of Antimicrobial Products in the FDA’s Centre for Drug Evaluation and Research.
‘This approval provides an additional treatment option for patients with cUTI, a type of serious bacterial infection.’
The safety and efficacy of Vabomere were evaluated in a clinical trial with 545 adults with cUTI, including those with pyelonephritis. At the end of intravenous treatment with Vabomere, approximately 98 per cent of patients treated with Vabomere compared with approximately 94 per cent 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 per cent of patients treated with Vabomere compared with approximately 73 per cent of patients treated with piperacillin / tazobactam had resolved symptoms and a negative urine culture.
The most common adverse reactions in patients taking Vabomere were headache, infusion site reactions and diarrhea. Vabomere is associated with serious risks including allergic reactions and seizures. Vabomere should not be used in patients with a history of anaphylaxis, a type of severe allergic reaction to products in the class of drugs called beta-lactams.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of antibacterial drugs, Vabomere should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.