The Food and Drug Administration (FDA) has approved Vabomere (meropenem and vaborbactam; The Medicines Company) for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Enterobacteriaceae: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex.
Vabomere is a combination antibiotic that includes meropenem, a penem antibacterial, and vaborbactam, a non-suicidal beta-lactamase inhibitor. Meropenem inhibits cell wall synthesis and vaborbactam protects meropenem from degradation by specific serine beta-lactamases; it has no antibacterial activity.
The FDA approval was based on data from a Phase 3 multi-center, randomized, double-blind, double-dummy study, TANGO-I (n=550), of adults with cUTI, including those with pyelonephritis. The primary endpoint was the overall cure or improvement and microbiologic outcome of eradication (defined as baseline bacterial pathogen reduced to <104 CFU/mL).
The data showed about 98.4% of patients treated with intravenous (IV) Vabomere exhibited cure/improvement in symptoms and a negative urine culture test vs. 94.3% of patients treated with piperacillin/tazobactam. About one week post-treatment, ~77% of patients treated with Vabomere had symptom resolution and a negative urine culture vs. 73% of patients treated with piperacillin/tazobactam.
Headache, infusion site reaction, and diarrhea were the most common adverse events associated with Vabomere.
Vabomere will be available as a 2g strength powder in single-dose vials in 6-count cartons. It is anticipated to launch in the 4th quarter of 2017.
For more information call (888) 977-6326 or visit Vabomere.com.