On June 17 local time, GSK and Spero Therapeutics jointly announced that the U.S. Food and Drug Administration (FDA) has approved Utebzi (tebipenem pivoxil), an oral antibiotic, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, in adults caused by certain susceptible pathogens, where patients have limited or no available oral treatment options.
This is the first and only approved oral carbapenem antibiotic for this patient population.
The approval is supported by positive results from the PIVOT-PO Phase III trial (NCT06059846). The PIVOT-PO trial was a global, randomized, double-blind, pivotal, non-inferiority (non-inferiority margin: -10%) Phase III trial designed to evaluate the therapeutic potential of oral Utebzi compared with intravenous (IV) imipenem-cilastatin in hospitalized adults with cUTIs, including acute pyelonephritis.
The trial demonstrated that Utebzi was non-inferior to IV imipenem-cilastatin in hospitalized patients with cUTIs, including pyelonephritis, based on overall response (a composite of clinical cure and microbiological eradication) at the test-of-cure visit. The overall success rate for Utebzi (oral, 600 mg) was 58.5% (261/446), compared with 60.2% (291/483) for IV imipenem-cilastatin (500 mg) (adjusted treatment difference: -1.3%; 95% CI: -7.5%, 4.8%).
The safety profile of Utebzi was generally similar to that of imipenem-cilastatin and other carbapenems. The most frequently reported adverse events (incidence ≥3%) were diarrhea and headache; these events were mild or moderate in severity and not serious.
Carbapenems are the standard of care for treating severe or resistant infections, but until now, they have only been available via intravenous administration, which increases hospital resource utilization and reduces patients’ quality of life. With the approval of Utebzi, it is expected to become an effective oral alternative therapy that can be used outside of the hospital setting.
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