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The US Food and Drug Administration (FDA) has granted priority review to GSK’s new drug application for the oral antibiotic gepotidacin.

The drug, primed for the management of uncomplicated urinary tract infections, could be the first in a new class of antibiotics for the infection in more than two decades.

About gepotidacin

Gepotidacin is a late-stage investigational triazaacenaphthylene antibiotic that acts by blocking bacterial DNA replication.

It does this through a unique binding site, exhibiting a new mechanism of action, and, for the majority of pathogens, offers well-balanced inhibition of two distinct Type II topoisomerase enzymes.

The drug is a discovery of GSK, and development has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority (BARDA).

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The application and subsequent priority review are based on positive data from two Phase III clinical trials coded EAGLE-2 and EAGLE-3.

These studies found that among female adults and adolescent patients with uncomplicated urinary tract infections and a nitrofurantoin-susceptible uropathogen, gepotidacin showed better efficacy compared to nitrofurantoin.

At the time of analysis, EAGLE-3 showed that 58.5% of patients who took gepotidacin achieved therapeutic success compared to 43.6% of those who had ingested nitrofurantoin.

While in EAGLE-2, gepotidacin showed therapeutic efficacy in 50.6% compared to 47.0% in nitrofurantoin use.

In the studies, 1.5 g of gepotidacin was administered twice daily for five days as an oral dose, while 100 mg of nitrofurantoin was given twice daily for five days.

The two trials had a combined total of 3136 participants.

In terms of safety and tolerability, gepotidacin predisposed patients to mild and moderate gastrointestinal adverse events, including nausea and diarrhea.

Conclusion

This discovery and approval is critical for an infection that affects 50% of women during their lifetime and is characterized by substantial patient morbidity with discomfort and inhibition in performing normal daily tasks.

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