GSK and Spero Therapeutics announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated Urinary Tract Infections (cUTIs) including pyelonephritisa, caused by certain susceptible pathogens in adult patients who have limited or no alternative oral treatment options. This is the first and only oral carbapenem antibiotic approved for these patients. This approval is a result of GSK’s development and exclusive global licensing agreement (excluding select Asian territories) with Spero Therapeutics.

There are more than 3 million cases of cUTI in the US annually and treatment failure impacts up to 34 percent of patients. Often caused by multidrug-resistant pathogens, these infections account for over USD 6 billion per year in healthcare costs. Carbapenems are the standard treatment for severe or resistant infections, but until now, have only been available through intravenous administration, increasing hospital resource use and reducing patients’ quality of life. Tebipenem pivoxil offers the potential for an effective oral alternative taken outside of a hospital setting.

Tony Wood, Chief Scientific Officer, GSK, said, “With antibiotic resistance continuing to rise, patients and healthcare professionals need new treatment options. The approval of Utebzi provides the first and only oral carbapenem antibiotic for appropriate adults with complicated UTIs, a solution that could help reduce reliance on hospital-based intravenous care and support efforts to address resistant infections.”

Esther Rajavelu, President and Chief Executive Officer (CEO), Spero Therapeutics, added, “The FDA approval of tebipenem pivoxil marks the culmination of more than a decade of dedication from our team, partners, and, most importantly, the patients who placed their trust in this program. We are proud to reach this important milestone. Through our partnership with GSK, we look forward to this much-needed oral treatment option reaching cUTI patients to help reduce the burden of the disease.”

This approval is supported by positive results from the PIVOT-PO phase 3 trial, which demonstrated non-inferiority of tebipenem pivoxil compared to intravenous imipenem-cilastatin in hospitalised patients with cUTI, including pyelonephritis, based on the overall response (composite of clinical cure plus microbiological eradication) at the test of cure visit. Tebipenem pivoxil (oral, 600 mg) achieved a 58.5 percent overall success rate (261/446 participants) compared to 60.2 percent overall success rate (291/483 participants) for imipenem-cilastatin (intravenous, 500 mg) (adjusted treatment difference: −1.3 percent; 95 percent CI: −7.5 percent, 4.8 percent).

The safety profile of tebipenem pivoxil was generally similar to that of imipenem-cilastatin and other carbapenem antibiotics. The most frequently reported Adverse Events (AEs) (in ≥3 percent of patients) were diarrhea and headache; these events were all mild or moderate and non-serious.

Tebipenem pivoxil is anticipated to be made available to US patients by the end of 2026. With this approval, GSK builds on recent advances in its growing anti-infectives portfolio.

This approval confirms the collaboration between GSK and Spero Therapeutics. The development of tebipenem pivoxil has been supported in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract numbers HHSO100201800015C and HHSO100201300011C.