GSK and Spero Therapeutics have received FDA approval for Utebzi — the first oral carbapenem antibiotic cleared in the U.S. — indicated for complicated urinary tract infections (cUTIs), including pyelonephritis, in adults.
The approval is based on the phase 3 PIVOT-PO trial, which showed Utebzi was noninferior to IV imipenem-cilastatin, with overall success rates of 58.5% versus 60.2%, respectively. The significance here is the oral route: cUTIs, particularly those caused by ESBL-producing Enterobacterales (E. coli and K. pneumoniae being the dominant culprits), have historically required IV treatment when standard oral options fail. Utebzi changes that calculus for step-down therapy and potentially full outpatient treatment, affecting an estimated 2.9 million U.S. patients annually.
The drug was originally developed by Meiji Seika Pharma in Japan, where it has been available as an oral pediatric antibiotic since 2009. Spero licensed the compound and conducted the U.S. clinical program; GSK subsequently acquired the global rights from Spero.