The FDA has approved tebipenem pivoxil (Utebzi) tablets as the first oral carbapenem antibiotic to treat complicated urinary tract infections (UTIs), reports MedPage Today.
Tebipenem pivoxil is indicated for complicated UTIs, including pyelonephritis, caused by the susceptible micro-organisms Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis, in adults who have limited or no alternative oral treatment options.
The approval was based on the phase 3 PIVOT-PO trial, where oral tebipenem pivoxil proved non-inferior to IV imipenem-cilastatin in hospitalised patients with complicated UTIs, including acute pyelonephritis.
At day 17, 58.5% of patients randomised to the oral carbapenem responded compared with 60.2% of patients treated with the IV antibiotic, a finding that was enough to stop the trial early.
“For patients with complicated UTIs and their caregivers, this approval is a major milestone,” said Bilal Chughtai, MD, of Northwell Health in New York in a press release from drugmaker GSK.
Complicated UTIs include those that happen in male, pregnant, or immunocompromised patients, as well as infections that involve the kidneys or are linked to fevers, stones, urinary obstruction, catheters, or sepsis. Associated with significant morbidity and mortality, complicated UTIs are increasingly caused by antimicrobial-resistant bacteria, including multidrug-resistant bacteria.
The infections lead to more than 620 000 hospital admissions annually in the United States.
Tebipenem pivoxil’s most common adverse events (at least 1%) in patients were diarrhoea, headache, nausea, abdominal pain, hepatic enzyme increases, and Clostridioides difficile infection.
The medication should be available to American patients by the end of 2026, GSK said.
MedPage Today article – First Oral Carbapenem Approved for Complicated UTIs (Open access)
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