The FDA has approved Vabomere, an intravenous antibiotic, for the treatment of complicated urinary tract infections (UTIs), including pyelonephritis, in adults.
The drug contains meropenem, a carbapenem antibiotic, and vaborbactam, which inhibits certain types of bacterial resistance mechanisms.
In a clinical trial that included 545 adults with complicated UTIs, including some with pyelonephritis, approximately 98% of patients treated with Vabomere had cure or improvement in symptoms and a negative urine culture test at the end of treatment compared with 94% of patients who received piperacillin/tazobactam, according to an FDA news release. About 7 days after completing treatment, some 77% of Vabomere recipients experienced resolution of symptoms and had a negative urine culture compared with 73% of those treated with piperacillin/tazobactam.
The most common adverse reactions associated with 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, according to the FDA.
The FDA granted approval of Vabomere to Rempex Pharmaceuticals.