The Food and Drug Administration has approved Vabomere (meropenem and vaborbactam) for adults with complicated urinary tract infection (cUTI), including pyelonephritis caused by susceptible Enterobacteriaceae, the agency has announced.
The approval was based on results of the TANGO 1 trial , a phase 3, multicenter, double-blind study of 545 adult patients with cUTI. Overall, 98.4% of patients treated with Vabomere saw improvement in symptoms and negative urine culture tests by the end of intravenous treatment, compared with 94.3% of those treated with piperacillin/tazobactam (95% confidence interval, 0.3%-8.8%). Improvement continued in about 77% of patients treated with Vabomere who had resolved symptoms 7 days after completing treatment, compared with about 73% of those who were treated with piperacillin/tazobactam, the FDA said Aug. 29 in a press release.
Vabomere contains meropenem, an antibacterial, and vaborbactam, a potent selective beta-lactamase inhibitor. The drug is administered intravenously, and the recommended dosage is 4 grams (meropenem 2 grams and vaborbactam 2 grams) in a 3-hour infusion every 8 hours in patients aged 18 and older, the drug’s developer, The Medicines Company, said in a statement released Aug. 30. The recommended duration of treatment for Vabomere is up to 14 days.
Headache, infusion site reactions, and diarrhea were common adverse effects of Vabomere. The drug also has been associated with allergic reactions and seizures, so it should not be administered to patients with a history of anaphylaxis.
“Vabomere represents a significant new advancement in addressing [Klebsiella pneumoniae carbapenemase]-producing Enterobacteriaceae, for which there are currently limited treatment options,” Clive A. Meanwell, MD, PhD, chief executive officer of The Medicines Company, said in the statement.
Rempex Pharmaceuticals, a Medicines Company unit, received the approval. The Medicines Company said the drug is expected to be available before the end of the year.