The FDA has approved Spero Therapeutics’ oral antibiotic tebipenem pivoxil hydrobromide (Branded as Utebzi) for complicated urinary tract infections, including pyelonephritis, following years of regulatory back-and-forth. GSK-Spero said the approval came four years after the agency issued a complete response letter, with the current decision based on Phase III data demonstrating noninferiority versus intravenous imipenem-cilastatin. The approval supports an oral option for patients with cUTI, targeting the same clinical endpoints while shifting administration away from IV therapy. Utebzi is expected to be available by the end of 2026. Under a $600 million license agreement signed in September 2022, GSK received global rights to the product excluding Japan and certain Asian markets retained by Meiji Seika Pharma, with Spero having originally licensed rights from Meiji in 2017.