FDA Approves New Antibacterial Drug
The US Food and Drug Administration has approved Vabomere for adult patients with complicated urinary tract infections (cUTI), including pyelonephritis.
Vabomere is administered intravenously and contains meropenem, an antibacterial, and vaborbactam, which inhibits resistance mechanisms used by bacteria.
Approval was based on a clinical trial that included 545 adults with cUTI. Overall, approximately 98% of patients treated with Vabomere experienced improved symptoms or were cured and had negative urine culture tests by the end of treatment compared with approximately 94% of patients who received piperacillin/tazobactam. Approximately 77% of patients who received Vabomere experienced resolved symptoms and had negative urine cultures 7 days after treatment compared with 73% of patients treated with piperacillin/tazobactam.
Common adverse reactions associated with Vabomere included headache, infusion site reactions, and diarrhea. In addition, serious risks associated with Vabomere included allergic reactions and seizures. Patients with a history of anaphylaxis are not recommended to receive Vabomere.
FDA approves new antibacterial drug [press release]. FDA. August 29, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573955.htm. Accessed August 30, 2017.