FDA approves first-in-class oral antibiotic

The US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) antibiotic for uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients aged 12 years old and over.

The first-in-class bactericidal drug is indicated for such infections caused by Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.

Gepotidacin inhibits bacterial DNA replication by a distinct binding site, a novel mechanism of action. Its well-balanced inhibition for most pathogens means is anticipated to have a lower potential to develop bacterial resistance, according to GSK.

“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,” stated Tony Wood, Chief Scientific Officer, GSK.

“With an increasing number of patients experiencing recurrent infections, there remains a clear need for continued research of antimicrobials to help address ongoing patient challenges and the strain on healthcare systems,” explained Dr Thomas Hooton, Professor of Clinical Medicine, University of Miami School of Medicine.

Clinical data supporting the FDA’s approval of the Blujepa antibiotic

The FDA’s new authorisation of gepotidacin is based on findings from the pivotal Phase III EAGLE-2 and EAGLE-3 clinical trials. Data showed its non-inferiority to nitrofurantoin, a leading current standard of care treatment option for uncomplicated urinary tract infections.

The antibiotic demonstrated non-inferiority in therapeutic success attained by 50.6 percent of participants, compared to 47.0 percent for nitrofurantoin in the EAGLE-2 trial.

In EAGLE-3, therapeutic success for gepotidacin was achieved in 58.5 percent of participants compared to 43.6 percent for nitrofurantoin, GSK added.

Separately, the Blujepa antibiotic has shown promising non-inferiority to leading treatments for gonorrhoea, as shown in the first study of the global Phase III clinical programme for gepotidacin.