The FDA approved GSK and Spero Therapeutics’ Utebzi (tebipenem pivoxil) for adult complicated urinary tract infections. This oral antibiotic treats cUTIs and kidney infections in patients with limited or no other oral treatment options.
Utebzi is the first oral carbapenem antibiotic approved in the United States. The drug provides a take-home alternative to traditional intravenous treatments typically administered in hospitals.
The PIVOT-PO Phase III trial confirmed Utebzi is non-inferior to intravenous carbapenems for treating hospitalized adults. GSK expects the drug to be available to U.S. patients by the end of 2026.