The FDA has approved GSK’s antibiotic for adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain susceptible pathogens in adult patients who have limited or no alternative oral treatment options.
Tebipenem pivoxil is the first and only oral carbapenem antibiotic approved in the US.
Tony Wood, Chief Scientific Officer, GSK, said: “With antibiotic resistance continuing to rise, patients and healthcare professionals need new treatment options.
“The approval of [tebipenem pivoxil] 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.”
An alternative to intravenous care
There are more than 3m cases of cUTI in the US annually and treatment failure impacts up to 34% of patients.
The infections are often caused by multidrug-resistant pathogens and account for more than $6bn in healthcare costs every year.
Carbapenems are the standard treatment for severe or resistant UTIs but, until now, have only been available intravenously.
Tebipenem pivoxil marks an alternative therapy that can be taken outside of clinical settings.
Dr Bilal Chughtai, Chief of Urology, Plainview Hospital, Northwell Health and Associate Professor of Urology, Zucker School of Medicine at Hofstra/Northwell, said: “For patients with complicated urinary tract infections 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.”
Success from the PIVOT-PO trial
The approval is supported by 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 at the test of cure visit.
Oral tebipenem pivoxil at 600mg achieved a 58.5% overall success rate, compared to 60.2% for intravenous imipenem-cilastatin at 500mg.
The newly approved antibiotic is anticipated to be made available to US patients by the end of 2026.
Featured image: MagdaWygralak on Adobe Stock
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