FDA approves Utebzi (tebipenem pivoxil) as the first oral carbapenem antibiotic for complicated urinary tract infections

The U.S. Food and Drug Administration (FDA) has approved tebipenem pivoxil (Utebzi) for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in adults. This marks the first oral carbapenem antibiotic available in the U.S. for this indication. The approval was supported by results from the Phase 3 PIVOT-PO trial, which demonstrated that oral tebipenem HBr was non-inferior to intravenous imipenem-cilastatin in hospitalized patients with cUTI.