The U.S. Food and Drug Administration has approved a new GSK antibiotic for complicated urinary tract infections, including kidney infections such as pyelonephritis, caused by bacteria resistant to existing drugs. Marketed as Utebzi, it is the first carbapenem antibiotic available in pill form rather than as an intravenous infusion.
The approval is seen as important because complicated urinary infections are more dangerous than routine bladder infections. They can lead to treatment failure, prolonged hospitalization and serious complications, especially when the bacteria have become resistant to antibiotics. In the United States alone, more than 2.8 million such cases are treated each year.
The FDA decision was based on a phase 3 study of 1,690 hospitalized patients with complicated urinary tract infections. The new drug performed about as well as the standard IV treatment, imipenem-cilastatin, and the trial was stopped early because the results were positive.
Health experts say an oral option could shorten hospital stays, reduce pressure on hospitals and improve patients’ quality of life. GSK says the medicine could be a key alternative for patients who currently remain in hospital only to receive IV antibiotics. The company expects Utebzi to be available in the United States by the end of 2026, while no submission timeline has been announced yet for other regulators, including in Israel.
