GSK plc’s (GSK) Blujepa (gepotidacin) has been approved by the US Food and Drug Administration (FDA) to treat uncomplicated urinary tract infections (uUTIs) in female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) caused by susceptible microorganisms such as Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.
Blujepa, a first-in-class oral antibiotic with a unique mode of action, was discovered by GSK scientists and is a component of the company’s infectious diseases portfolio.
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.
Tony Wood
Up to 16 million women in the US are affected with uUTIs each year, making them the most prevalent illness in women. More than half of women will get uUTI at some point in their lives, and over 30% will experience at least one recurring episode. This can result in substantial patient burden, including discomfort and limitations on everyday activities. Since drug-resistant bacteria are increasingly causing uUTIs and increasing treatment failure rates, new therapies are required.
For many, uUTIs 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.
Thomas Hooton
The pivotal phase III EAGLE-2 and EAGLE-3 trials showed non-inferiority to nitrofurantoin, one of the top current standard of care options for uUTI, in female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with a confirmed uUTI. These findings served as the basis for the approval. In EAGLE-2, 50.6% (162/320) of participants experienced non-inferiority in therapeutic success with Blujepa, while 47.0% (135/287) experienced nitrofurantoin (covariate-adjusted treatment difference 4.3%, 95% CI (-3.6, 12.1)). Blujepa outperformed nitrofurantoin in EAGLE-3 in a statistically significant way (one-sided p-value 0.0003). In contrast to 43.6% (115/264) for nitrofurantoin (covariate-adjusted treatment difference 14.6%, 95% CI (6.4, 22.8)), 58.5% (162/277) of subjects experienced therapeutic success.
In the EAGLE-2 and EAGLE-3 phase III trials, Blujepa’s safety and tolerability profile matched those of earlier studies. Among Blujepa participants, gastrointestinal (GI) adverse events were the most frequently reported AEs. The most frequent symptom was diarrhea, which affected 16% of individuals, and nausea, which affected 9%. The most prevalent maximum severity among those who reported GI adverse events in the Blujepa group was mild (69% Grade 1), followed by moderate (28% Grade 2). Grade 3 GI events occurred in less than 1% of all participants and accounted for 3% of all GI events in patients. During the two studies, there was one significant adverse event associated with each of the two treatment arms (nitrofurantoin and buprepa).
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Blujepa (gepotidacin)
Scientists at GSK discovered Blujepa, a bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication through a unique mechanism of action, a distinct binding site, and, for the majority of pathogens, well-balanced inhibition of two distinct Type II topoisomerase enzymes. This offers activity against Neisseria gonorrhoeae, even isolates resistant to existing antibiotics, and the majority of target uropathogens, including Escherichia coli and Staphylococcus saprophyticus. Blujepa target-specific mutations in both enzymes are required to drastically alter susceptibility to Blujepa because most infections are well-balancedly inhibited by it. As a result, a decreased likelihood of resistance development is anticipated. Phase III clinical trials for gonorrhea and uUTI have shown efficacy and safety in patients, even those with drug-resistant bacteria.
Source: GSK
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