GSK and Spero Therapeutics said the FDA has approved Utebzi (tebipenem pivoxil), an oral antibiotic for adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain susceptible pathogens in patients who have limited or no alternative oral treatment options. The product is the first and only oral carbapenem antibiotic approved for this population and arises from a development and global licensing agreement (excluding select Asian territories) between GSK and Spero.
More than 3 million cUTI cases occur annually in the US, with treatment failure affecting up to 34% of patients. These infections, often driven by multidrug-resistant pathogens, are estimated to account for over $6 billion in healthcare costs each year. Carbapenems are standard therapy for severe or resistant infections but have previously been available only via intravenous administration, increasing reliance on hospital-based care and affecting patients’ quality of life. Tebipenem pivoxil provides an oral option that can be taken outside the hospital setting.
The approval is supported by results from the PIVOT-PO phase III trial in hospitalized adults with cUTI, including pyelonephritis. In that study, oral tebipenem pivoxil 600 mg demonstrated non-inferiority to intravenous imipenem‑cilastatin 500 mg based on overall response (clinical cure plus microbiological eradication) at the test-of-cure visit. Overall success was 58.5% (261/446) with tebipenem pivoxil and 60.2% (291/483) with imipenem‑cilastatin, with an adjusted treatment difference of −1.3% (95% CI: −7.5%, 4.8%).
The safety profile of tebipenem pivoxil was generally similar to that of imipenem‑cilastatin and other carbapenems. The most frequently reported adverse events, occurring in at least 3% of patients, were diarrhea and headache; all were mild or moderate and non-serious. Tebipenem pivoxil is expected to be available to US patients by the end of 2026.
The development of tebipenem pivoxil was supported in part by funding from the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response and the Biomedical Advanced Research and Development Authority under two federal contracts, and the companies described the project as a productive collaboration between industry and government.
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