GSK and Spero Therapeutics won FDA approval for Utebzi (tebipenem pivoxil hydrobromide), an oral antibiotic for complicated urinary tract infections (cUTI), including pyelonephritis. The agency’s approval followed a four-year gap after an earlier FDA complete response letter. Utebzi’s approval was based on phase III data showing noninferiority versus intravenous imipenem-cilastatin. The program targets a clinical need for effective oral therapy that can treat serious cUTI without relying on inpatient IV regimens. The approval is notable for how it validates the reworked clinical package after prior submission difficulties, and it also strengthens GSK-Spero’s antibiotic franchise through an oral option positioned for broader access. Spero said the product is expected to become available by the end of 2026. Under a $600 million license deal signed in 2022, GSK gained global rights with the exception of Japan and certain Asian markets covered by the original developer Meiji Seika Pharma.