FDA approves Utebzi tebipenem pivoxil, first oral carbapenem antibiotic in the US for complicated urinary tract infections
For drug-resistant complicated urinary infections, treatment has often meant a hospital stay and IV carbapenems. On June 17 the FDA approved Utebzi from GSK $GSK, the first oral carbapenem antibiotic in the US. A 1,690-patient phase 3 trial found the pill non-inferior to IV imipe
For patients facing drug-resistant complicated urinary tract infections, treatment has usually meant checking into a hospital for intravenous carbapenem antibiotics, the class often held in reserve for stubborn infections. That changed on June 17, when the US Food and Drug Administration approved Utebzi from GSK $GSK, the first oral carbapenem antibiotic cleared in the United States. It is indicated for adults with complicated urinary tract infections, including kidney infection, who have limited or no other oral treatment options. The approval rests on PIVOT-PO, a global phase 3 trial of 1,690 patients that compared the oral drug against intravenous imipenem-cilastatin. The pill proved non-inferior at the test-of-cure assessment, with overall response around 58.5 percent versus 60.2 percent for the IV comparator. The most common side effects were diarrhea and headache, reported as mild to moderate. An oral option matters because it could let some patients avoid hospital admission and IV lines while still reaching infections caused by resistant organisms such as E. coli and Klebsiella pneumoniae. GSK expects Utebzi to be available in the US by the end of 2026.