FDA approves new antibiotic drug for UTIs
Work by Keith Kaye, M.D., M.P.H., director of clinical research in the Michigan Medicine Division of Infectious Disease, helped fast-track the approval of a new drug for antibiotic-resistant urinary tract infections (UTIs).
The drug, Vabomere, was approved to treat complicated UTIs, including pyelonephritis, a potentially life-threatening infection caused by bacteria traveling from the bladder into one or both of the kidneys.
Kaye was principal investigator of the TANGO-2 trial which showed Vabomere improved clinical cure rates and resulted in less harm to kidneys compared to the best available therapy. The Food and Drug Administration fast-tracked the new drug, giving it priority review.
The treatment worked so well in the clinical trial led by Kaye, a member of the Institute for Healthcare Policy & Innovation, that an independent monitoring board overseen by the FDA recommended the study be stopped early.
Vabomere contains an antibacterial and an inhibitor which deters certain resistance mechanisms used by bacteria. It targets “superbug” infections known as carbapenem-resistant enterobacteriaceae (CRE).
Both the Centers for Disease Control and the World Health Organization view CRE infections as an urgent threat because they are resistant to the strongest antibiotics. CRE kills up to 50 percent of hospitalized patients when it becomes a bloodstream infection.
The drug, expected to be available later this year, promises less harmful side effects but should be used only to treat or prevent infections caused by susceptible bacteria, according to an FDA press release.
TANGO-2 trial results are expected to be presented at a future medical conference and published in a peer-reviewed journal.