FDA Approves New Antibacterial for UTIs

Rempex Pharmaceuticals’ antibacterial drug, Vabomere, has been approved by the US Food and Drug Administration (FDA) to treat adults with complicated urinary tract infections (cUTI). The drug is also indicated for the treatment of pyelonephritis, a type of serious kidney infection that can be difficult to treat with traditional antibacterial drugs.

“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.”

Vabomere is a dual-action therapy that combines an antibacterial drug, meropenem, with a bacterial resistance inhibitor, vaborbactam, to fight infection. By combining these two drugs, the medication could help eliminate bacterial infections caused by antibacterial-resistant microorganisms.

A clinical trial involving 545 adult volunteers with cUTI was conducted to evaluate the safety and efficacy of Vabomere. Vabomere was more effective at treating cUTI and pyelonephritis compared to the antibacterial combination of piperacillin/tazobactam, with 98 percent of patients treated with Vabomere being cured, or showing an improvement in symptoms, compared to 94 percent for the standard-of-care.

Seventy-seven percent of patients taking Vabomere showed a negative urine culture about one week after they completed their course of treatment. This is compared to 73 percent of patients treated with piperacillin/tazobactam.

The FDA warns that Vabomere should not be prescribed to all patients with a cUTI or pyelonephritis. The strong antibacterial should only be used to treat patients whose infection is thought to be caused by bacterial species susceptible to the treatment, in order to prevent other strains from becoming resistant to the drug combo.

Approximately 100,000 patients in the US visit the ER each year due to a kidney infection, according to the National Institutes of Health (NIH). If left untreated, kidney infections can cause major complications, including kidney disease and kidney failure.