GSK-Spero’s oral antibiotic Utebzi (tebipenem pivoxil hydrobromide) cleared the U.S. FDA approval hurdle for complicated urinary tract infections, including pyelonephritis. The decision comes four years after the agency issued a complete response letter for the same drug candidate. FDA approved Utebzi based on Phase 3 data showing noninferiority to intravenous imipenem-cilastatin. Under the approval, the companies said the product is expected to become available by the end of 2026. The approval marks a meaningful shift from IV carbapenem therapy toward an oral option intended to improve convenience and potentially reduce inpatient reliance, while maintaining comparable clinical effectiveness. The asset is supported by a licensing structure from Spero and Meiji Seika, with GSK having obtained global rights under a $600 million deal signed in 2022, excluding Japan and certain Asian territories covered by the original developer agreements.