GSK plc and Spero Therapeutics announced that the US Food and Drug Administration (FDA) has approved Utebzi(tebipenem pivoxil). It is indicated for adult patients with complicated urinary tract infections (cUTIs), including pyelonephritis, who have limited or no alternative oral treatment choices.
Utebzi makes history as the first and only oral carbapenemantibiotic approved in the United States. Previously, carbapenems the standard of care for severe or drug-resistant infections could only be administered intravenously, requiring significant hospital resources and decreasing patient quality of life. Utebzi offers an effective oral alternative that can be taken outside of the hospital setting.
The FDA approval is based on data from the global Phase III PIVOT-PO trial. The trial demonstrated that oral tebipenempivoxil achieved non-inferiority to intravenous imipenem-cilastatin regarding overall success rates, while maintaining a similar safety profile.
Supported in part by federal BARDA funds, Utebzi is anticipated to be available to patients in the US by the end of 2026.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
