The US Food and Drug Administration (FDA) has approved GSK’s triazaacenaphthylene antibiotic, Blujepa (gepotidacin), for treating uncomplicated urinary tract infections (uUTIs) in adult females and paediatric patients weighing 40kg and above.
The approval is indicated for children aged 12 years and above. It is for uUTIs caused by susceptible micro-organisms such as Escherichia coli, Citrobacter freundii complex, Enterococcus faecalis, Klebsiella pneumonia and Staphylococcus saprophyticus.
Go deeper with GlobalData
Blujepa’s approval stems from the positive outcomes of the pivotal Phase III trials, EAGLE-2 and EAGLE-3.
These trials showed the therapy’s non-inferiority to nitrofurantoin, a current standard of care for the condition, and even showed statistical superiority in the EAGLE-3 trial.
GSK chief scientific officer Tony Wood stated: “The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women.
“We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.”
In the EAGLE-2 trial, the therapy achieved a therapeutic success rate of 50.6% against 47% for nitrofurantoin.
The therapy’s tolerability and safety profile in these trials was found to be consistent with earlier studies.
Commercial launch in the US is planned for the second half of this year.
Blujepa’s development has been partly financed by federal funds from the US Department of Health and Human Services, the Biomedical Advanced Research and Development Authority, the Administration for Strategic Preparedness and Response, and the Defense Threat Reduction Agency.
It works by blocking bacterial DNA replication through a unique binding site, offering a new approach to tackling pathogens and offering balanced blocking of Type II topoisomerase enzymes.
GSK achieved breakthrough therapy designation from the FDA for its B7-H3-targeted antibody-drug conjugate, GSK’227, for the treatment of relapsed or refractory osteosarcoma in adults in January 2025.
