Philadelphia — GSK plc and Spero Therapeutics said the U.S. Food and Drug Administration has approved Utebzi, an oral antibiotic for adults with complicated urinary tract infections, including pyelonephritis, who have limited or no alternative oral treatment options.
The companies said Utebzi, also known as tebipenem pivoxil, is the first and only oral carbapenem antibiotic approved in the United States for these patients. The approval covers infections caused by certain susceptible pathogens.
The approval follows a development and exclusive global licensing agreement between GSK and Spero Therapeutics, excluding certain Asian territories.
Complicated urinary tract infections affect more than 3 million people in the United States each year, according to the companies. Treatment failure affects up to 34 percent of patients, and the infections are often caused by multidrug-resistant pathogens.
Carbapenems are commonly used to treat severe or resistant infections, but until now they have only been available through intravenous administration. The companies said Utebzi could provide an oral alternative that may be taken outside a hospital setting.
“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,” said Tony Wood, Chief Scientific Officer at GSK.
Dr. Bilal Chughtai, Chief of Urology at Plainview Hospital, Northwell Health and Associate Professor of Urology at the Zucker School of Medicine at Hofstra/Northwell, said the approval is an important milestone for patients and caregivers.
“For patients with complicated urinary tract infections (cUTIs) and their caregivers, this approval is a major milestone as today’s standard of care places a serious burden on them and hospitals. A new effective oral treatment offering an alternative option to intravenous care has the potential to enable more treatment in the outpatient settings with the ambition to improve their experience,” Chughtai said.
Esther Rajavelu, President and Chief Executive Officer of Spero Therapeutics, said the approval follows more than a decade of work on the program.
“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,” Rajavelu said.
The approval is based on results from the Phase 3 PIVOT-PO trial, which showed that oral tebipenem pivoxil was non-inferior to intravenous imipenem-cilastatin in hospitalized patients with complicated urinary tract infections, including pyelonephritis.
In the trial, tebipenem pivoxil, given orally at 600 mg, achieved an overall success rate of 58.5 percent, or 261 of 446 participants. Intravenous imipenem-cilastatin, given at 500 mg, achieved an overall success rate of 60.2 percent, or 291 of 483 participants.
The adjusted treatment difference was minus 1.3 percent, with a 95 percent confidence interval of minus 7.5 percent to 4.8 percent.
