Antibacterial regimen of meropenem-vaborbactam showed superior efficacy and comparable tolerability compared with piperacillin/tazobactam (Zosyn).
The FDA yesterday approved Vabomere for patients with complicated urinary tract infections (cUTI), including pyelonephritis, a bacterial kidney infection, according to the release.
Vabomere is a combination of meropenem, an antibacterial drug, and varborbactam, a drug that inhibits resistance mechanisms used by bacteria.
“The FDA is committed to making new safe and effective antibacterial drugs available,” said Edward Cox, MD, 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.”
The safety and efficacy of Vabomere were assessed in a clinical trial of 545 patients with cUTI, including patients with pyelonephritis.
The investigators found that 98% of patients treated with Vabomere had reduced symptoms and had a negative urine culture test compared with 94% of patients treated with piperacillin/tazobactam, according to the FDA.
After 7 days of treatment, 77% of patients treated with Vabomere had no symptoms and a negative urine culture, while 73% of patient treated with piperacillin/tazobactam.
These results show that Vabomere may be more effective than current antibacterial treatments.
The most common adverse reactions include headache, infusion site reactions, and diarrhea. The FDA warns that Vabomere can cause serious allergic reactions and seizures in some patients . Vabomere is not recommended for patients who have a history of anaphlaxsis to beta-lactam drugs, according to the release.
To lessen the risk of drug-resistant bacteria and do not lower the efficacy of antibacterial drugs, the FDA recommends that Vabomere should only be prescribed for infections that are caused by susceptible bacteria.
Vabomere was designated as a qualified infectious disease product, since it treats serious or life-threatening infections, according to the release.