GSK and Spero Therapeutics have announced the US Food and Drug Administration’s (FDA) approval of their new oral antibiotic for complicated urinary tract infections (cUTIs).
The medication, branded as Utebzi, is now the first and only oral carbapenem antibiotic available in the United States. This new treatment is designed to combat cUTIs caused by multidrug-resistant organisms, which have traditionally required intravenous (IV) carbapenem therapy.
Annually, the US sees over three million cases of cUTIs, with approximately one-third of these patients experiencing treatment failure due to antibiotic resistance.
GSK Chief Scientific Officer Tony Wood, PhD, emphasized the critical need for new therapeutic avenues as antibiotic resistance escalates, stating, "patients and healthcare professionals need new treatment options."
Clinical trials demonstrate comparable efficacy to IV carbapenems
The FDA’s decision was informed by the PIVOT-PO trial. This study indicated that tebipenem pivoxil demonstrated noninferiority when compared to IV imipenem-cilastatin in hospitalized patients diagnosed with cUTI, including pyelonephritis (kidney infection). This conclusion was based on the overall patient response observed at the test-of-cure evaluation.
The combined success rate for tebipenem pivoxil, encompassing both clinical cure and microbiologic eradication, was 58.5%. This figure was closely followed by imipenem-cilastatin at 60.2%, resulting in an adjusted treatment difference of –1.3% (within the noninferiority margin of –10%).
The safety profile of tebipenem pivoxil was found to be similar to imipenem-cilastatin and other carbapenems. The trial was concluded ahead of schedule due to demonstrated efficacy.
Tebipenem pivoxil was originally developed by Spero Therapeutics. A licensing agreement was established in 2022 between GSK and Spero, granting GSK the rights to develop and commercialize the drug globally, excluding Asia. This partnership provided Spero with the necessary funding to conduct the PIVOT-PO trial, which involved 1,690 patients hospitalized with cUTIs, including pyelonephritis.
Esther Rajavelu, MBA, President and CEO of Spero Therapeutics, expressed optimism about the drug’s potential impact, stating, "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."