The FDA has approved Utebzi (tebipenem pivoxil), an oral antibiotic for the treatment of complicated urinary tract infections, including pyelonephritis, in adults who have limited or no alternative oral treatment options.
The approval makes Utebzi the first and only oral carbapenem antibiotic approved in the U.S., according to a June 17 news release from GSK and Spero Therapeutics. Carbapenems are a standard treatment for severe or resistant infections but previously were available only through intravenous administration. GSK said tebipenem pivoxil is expected to be available to U.S. patients by the end of 2026.
The approval was based on results from the phase 3 Pivot-Po trial, which demonstrated noninferiority compared with intravenous imipenem-cilastatin in hospitalized patients with complicated urinary tract infections. Tebipenem pivoxil achieved a 58.5% overall success rate, compared with 60.2% for imipenem-cilastatin.
More than 3 million cases of complicated urinary tract infections are treated annually in the U.S., and treatment failure affects up to 34% of patients, according to the release. The infections account for more than $6 billion in annual healthcare costs and are often caused by multidrug-resistant pathogens.
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