PHILADELPHIA, PA — GSK (LSE: GSK; NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) said the U.S. Food and Drug Administration has approved Utebzi, the first oral carbapenem antibiotic for adults with complicated urinary tract infections who have limited or no alternative oral treatment options, potentially expanding outpatient treatment for drug-resistant infections.
The approval addresses a longstanding gap in treatment for complicated urinary tract infections, including pyelonephritis, where carbapenem antibiotics have traditionally required intravenous administration in hospitals or infusion settings.
According to the companies, more than 3 million complicated urinary tract infections occur annually in the United States, with treatment failures affecting up to 34% of patients. The infections are frequently associated with multidrug-resistant bacteria and account for more than $6 billion in annual healthcare costs.
“With antibiotic resistance continuing to rise, patients and healthcare professionals need new treatment options,” said Tony Wood, GSK’s chief scientific officer. “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.”
The drug, known generically as tebipenem pivoxil, was approved for infections caused by certain susceptible bacterial pathogens, including Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis.
FDA approval was supported by results from the Phase III PIVOT-PO trial, which compared oral tebipenem pivoxil with intravenous imipenem-cilastatin in hospitalized patients with complicated urinary tract infections. The study demonstrated non-inferiority, with overall treatment success rates of 58.5% for tebipenem pivoxil and 60.2% for imipenem-cilastatin at the test-of-cure visit.
“For patients with complicated urinary tract infections and their caregivers, this approval is a major milestone as today’s standard of care places a serious burden on them and hospitals,” said Dr. Bilal Chughtai, chief of urology at Plainview Hospital and associate professor at the Zucker School of Medicine at Hofstra/Northwell. He said an effective oral alternative could enable more treatment in outpatient settings.
The safety profile was generally consistent with other carbapenem antibiotics, with diarrhea and headache reported as the most common adverse events. The companies said those events were typically mild to moderate.
The approval stems from GSK’s licensing agreement with Spero Therapeutics, which retains certain rights in select Asian markets. The development program also received support from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
GSK said Utebzi is expected to become available to U.S. patients by the end of 2026.
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