GSK and Spero Therapeutics have announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic, for the treatment of complicated urinary tract infections (cUTIs) in adults.
The drug is the first and only carbapenem antibiotic approved in the US for patients and the approval expands GSK's growing portfolio of anti-infectives.
In the US, more than 3 million cases of cUTIs occur annually, with treatment failure affecting up to 34% of patients.
Caused by multidrug-resistant pathogens, these infections lead to healthcare costs exceeding $6bn each year.
While carbapenems are the standard treatment for severe cases, their intravenous administration increases hospital resource use and impacts patients' quality of life.
Tebipenem pivoxil is a promising oral alternative that may improve access to treatment and patient comfort.
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 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 programme."
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.
In its statement, GSK said the approval had been triggered by positive results from the PIVOT-PO Phase III trial, which demonstrated that tebipenem pivoxil performed on par with intravenous imipenem-cilastatin in hospitalised patients with cUTI.
The safety profile of tebipenem pivoxil was also similar to that of imipenem-cilastatin and other carbapenem antibiotics, with GSK adding that the most frequently reported adverse events were mild-to-moderate cases of diarrhoea and headache.
Tebipenem pivoxil is expected to be available to patients in the US by the end of this year.
