---

The US Food and Drug Administration (FDA) has approved GSK’s brand of gepotidacin (Blujepa) for the treatment of uncomplicated urinary tract infections in both pediatric and female adult patients.

The drug is a first-in-class oral antibiotic that demonstrates a novel mechanism of action—the first in three decades - against a disease that affects more than 50% of women globally.

More about gepotidacin

Gepotidacin is a GSK-discovered triazaacenaphthylene antibiotic that inhibits bacterial DNA replication through a unique binding site that, for most microorganisms, provides a well-balanced inhibition of two different Type II topoisomerase enzymes.

The drug’s target-specific mutations in both enzymes are needed to significantly affect susceptibility to gepotidacin, creating a lower propensity of resistance development.

Some microbes shown to be susceptible to the novel antibiotic include common resistant strains such as Escherichia coli, Klebsiella pneumoniae, and Citrobacter freundii complex.

---

READ ALSO: GSK Kenya rebrands to Haleon Kenya Ltd

---

About the clinical trials

Positive findings from the pivotal phase III EAGLE-2 and EAGLE-3 trials, which showed non-inferiority to nitrofurantoin (one of the top current standards of care options for UTI) in female adults and pediatric patients with a confirmed uncomplicated UTI, served as the basis for the FDA approval.

In EAGLE-2, Blujepa showed non-inferiority in therapeutic effectiveness, which occurred in 50% of the patients compared to 47% for nitrofurantoin. 

Additionally, in EAGLE-3, Blujepa demonstrated a statistically significant superior efficacy with therapeutic effectiveness occurring in 58.5% compared to 43.6% in nitrofurantoin.

What was said

 "For many, uncomplicated UTIs can be a burden that severely impacts daily life. 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," stated Thomas Hooton, professor of clinical medicine at the University of Miami School of Medicine.

"The approval of Blujepa is a crucial milestone, with uncomplicated UTIs among the most common infections in women. We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uncomplicated UTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments,” said Tony Wood, Chief Scientific Officer, GSK.

Safety and tolerability

During the EAGLE-2 and EAGLE-3 phase III trials, the most common reported adverse event among study participants on Blujepa was gastrointestinal, including symptoms such as diarrhea and nausea, most of which were categorized as mild.

 

The launch of Blujepa is expected in the second half of 2025.

---

Did you find this informative? Subscribe for more.

---