GSK and Spero Therapeutics received FDA approval for Utebzi (tebipenem pivoxil) to treat complicated urinary tract infections (cUTIs) and pyelonephritis. This medication is the first and only oral carbapenem antibiotic available for these infections. It provides a new option for patients who would otherwise require intravenous (IV) therapy.
The approval follows the PIVOT-PO phase III clinical trial comparing oral Utebzi to an IV carbapenem in hospitalized adults. Utebzi demonstrated a 58.5% overall success rate. The IV treatment comparator showed a 60.2% success rate, confirming the drug's non-inferiority.
The new treatment may reduce hospital stays by offering a more convenient administration format. Over 3 million people in the U.S. are affected by cUTIs annually.