The US Food and Drug Administration has approved a new carbapenem antibiotic from GSK Plc to treat complicated urinary tract infections – the first oral treatment of its kind for the disease. The authorisation, announced on 17 June, is for Utebzi (tebipenem pivoxil), a broad-spectrum carbapenem antibiotic of the beta-lactam class. The treatment will be available as a tablet, in addition to its availability as an in-hospital intravenous therapy.
Commenting on the approval, Tony Wood, GSK’s chief scientific officer, said the tablet “could help reduce reliance on hospital-based intravenous care and support efforts to address resistant infections.” The standard of care for urinary tract infections depends on the severity of the disease. In the Phase 3 trial supporting GSK’s regulatory application, Utebzi was compared with intravenous imipenem-cilastatin, an antibiotic which is on the World Health Organization’s List of Essential Medicines.
The trial established Utebzi’s’ non-inferiority to imipenem-cilastatin.with an overall success rate of 58.5% compared with 60.2% for the comparator. The safety profile of the new antibiotic was similar to that of imipenem-cilastatin and other carbapenem antibiotics.
GSK in-licensed tebipenem pivoxil in 2022 from Cambridge, US,-based Spero Therapeutics Inc which in turn had a partnership covering the product with Meiji Seika Pharma Co Ltd of Japan. GSK paid $66 million upfront for rights to the antibiotic. Potential milestone payments were $525 million at the time. Following FDA approval, GSK now holds global commercialisation rights for the product except for certain Asian territories where Meiji Seika retains rights.
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