The US Food and Drug Administration (FDA) has approved tebipenem pivoxil (Utebzi), an oral antibacterial therapy for adults with complicated urinary tract infections (cUTIs), including pyelonephritis, who have limited or no oral treatment options. According to GSK, tebipenem pivoxil is the first and only oral carbapenem antibiotic approved in the US.
Complicated urinary tract infections can affect the upper or lower urinary tract and are more likely to be caused by drug-resistant bacteria than uncomplicated urinary tract infections. Symptoms may include lower back pain, fever, chills, nausea, and vomiting.
The approval was supported by findings from the phase 3 PIVOT-PO trial, a global randomized, double-blind, double-dummy, noninferiority study that enrolled 1,690 hospitalized patients with cUTIs, including pyelonephritis. Patients were randomly assigned to receive tebipenem pivoxil 600 mg orally every 6 hours or imipenem-cilastatin 500 mg intravenously every 6 hours for 7 to 10 days. Efficacy was evaluated in an intent-to-treat population of 929 patients.
Efficacy was assessed as a composite of clinical cure, defined as resolution of infection signs and symptoms, and microbiological response, defined as reduction of baseline pathogens at follow-up. Results from the PIVOT-PO trial showed that oral tebipenem pivoxil performed similarly to intravenous imipenem-cilastatin.
The most common adverse reactions reported with tebipenem pivoxil were diarrhea, headache, nausea, abdominal pain, increased liver enzymes, and Clostridioides difficile infection.
According to the FDA, patients with allergic reactions to tebipenem pivoxil or other beta-lactam antibacterials, as well as those with primary or secondary carnitine deficiency or inborn metabolism errors that may result in clinically significant carnitine deficiency, should not take the drug.
The FDA granted tebipenem pivoxil Priority Review, Fast Track designation, and Qualified Infectious Disease Product designation for this indication.
