Vabomere (meropenem and vaborbactam), an injection for treating adult patients with complicated urinary tract infections (cUTIs) will be available in the United States. by the end of 2017. Rempex Pharmaceuticals was granted approval for the antibiotic by the US Food and Drug Administration (FDA), which designated the drug a qualified infectious disease product.
FDA approval was granted following a clinical trial involving 545 adults with cUTI, including patients with pyelonephritis. The study found 98 percent of those given Vabomere intravenously were cured or demonstrated an improvement of symptoms and negative urine test following treatment. This was four percentage points higher than the level seen in patients treated with piperacillin/tazobactam, an alternative antibacterial drug.
Vabomere was granted priority review by the FDA and consequently was eligible for its fast-track program. It addresses gram-negative bacteria, which produce beta lactamase enzymes, particularly the Klebsiella pneumoniae carbapenemase (KPC) enzyme, which the Centers for Disease Control and Prevention (CDC) classifies as an urgent antimicrobial resistance threat.
Clive Meanwell, MD, PhD, chief executive officer of The Medicines Company, which acquired Rempex Pharmaceuticals in 2013, stated: "Vabomere represents a significant new advancement in addressing KPC-producing Enterobacteriaceae, for which there are currently limited treatment options." Other options available for treating cUTIs include fluoroquinolone antibiotics such as Levofloxacin (levofloxacin) and Cipro (ciprofloxacin)
Who can take Vabomere?
Vabomere is indicated for the treatment of patients 18 or older with cUTIs, including pyelonephritis caused by designated susceptible bacteria. Usage of the drug should be limited to reduce the development of drug-resistant bacteria and maintain the effectiveness of Vabomere. Consequently, healthcare professionals are advised to prescribed Vabomere only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
It is contraindicated in patients with known hypersensitivity to Vabomere, as well those with anaphylactic reactions to beta-lactams.
Common Side Effects of Vabomere
The most common side effects and adverse reactions were headaches, phlebitis/infusion site reactions, and diarrhea.
For more information on Vabomere, visit http://www.vabomere.com/media/pdf/vabomere-us-prescribing-information.pdf
