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Drugmakers GSK and Spero Therapeutics announced yesterday that the US Food and Drug Administration (FDA) has approved their investigational oral antibiotic for complicated urinary tract infections (cUTIs).
Marketed under the brand name Utebzi, tebipenem pivoxil is the first and only oral carbapenem antibiotic approved in the United States. The antibiotic targets cUTIs caused by multidrug-resistant organisms, which have been typically treated with intravenous (IV) carbapenems.
More than three million cUTIs occur in the United States annually, and roughly one-third of patients experience treatment failure because of drug resistance.
“With antibiotic resistance continuing to rise, patients and healthcare professionals need new treatment options,” GSK Chief Scientific Officer Tony Wood, PhD, said in a company press release.
Trial data show noninferiority compared with IV carbapenems
The FDA approval was based on the results of the PIVOT-PO trial, which found that tebipenem pivoxil was noninferior to IV imipenem-cilastatin in hospitalized patients with cUTI, including pyelonephritis (kidney infection), based on the overall response at the test-of-cure visit.
Tebipenem pivoxil’s overall success rate (a composite of clinical cure plus microbiologic eradication) was 58.5%, compared with 60.2% for imipenem-cilastatin, for an adjusted treatment difference of –1.3%. (The noninferiority margin was –10%).
The safety profile was similar to that of imipenem-cilastatin and other carbapenems. The trial was stopped early for efficacy.
With antibiotic resistance continuing to rise, patients and healthcare professionals need new treatment options.
Tebipenem pivoxil was initially developed by Spero Therapeutics. In 2022, GSK signed a licensing agreement with Spero to develop and commercialize the drug in all markets except Asia. That deal provided the financing for Spero to conduct the PIVOT-PO trial, which involved 1,690 patients hospitalized with cUTIs, including pyelonephritis.
“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,” said Spero Therapeutics President and CEO Esther Rajavelu, MBA.