GSK says US FDA approves urinary tract infection treatment Utebzi
GSK PLC and Spero Therapeutics Inc on Wednesday said that the US Food & Drug Administration has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections.
The London-based pharmaceuticals firm said the approval is a result of its development and exclusive global licensing agreement, excluding select Asian territories, with Massachusetts-based Spero Therapeutics.
GSK’s Chief Scientific Officer Tony Wood said: ‘The approval of Utebzi provides the first and only oral carbapenem antibiotic for appropriate adults with complicated UTIs, a solution that could help reduce reliance on hospital-based intravenous care and support efforts to address resistant infections.’
Esther Rajavelu, president and chief executive officer, Spero Therapeutics said the approval marks the culmination of ‘more than a decade of dedication.’
‘We are proud to reach this important milestone. Through our partnership with GSK, we look forward to this much-needed oral treatment option reaching cUTI patients to help reduce the burden of the disease,’ she added.
The approval is supported by positive results from the Pivot-Po phase III trial, which demonstrated non-inferiority of tebipenem pivoxil compared to intravenous imipenem-cilastatin in hospitalised patients with cUTI, including pyelonephritis, based on the overall response at the test of cure visit.
Tebipenem pivoxil achieved a 58.5% overall success rate compared to 60.2% overall success rate for imipenem-cilastatin.
The safety profile of tebipenem pivoxil was generally similar to that of imipenem-cilastatin and other carbapenem antibiotics.
Tebipenem pivoxil is anticipated to be made available to US patients by the end of 2026.
GSK closed 1.1% higher at 1,971.69 pence each in London on Wednesday.
Copyright 2026 Alliance News Ltd. All Rights Reserved.