LONDON (dpa-AFX) - GSK plc. (GSK, GSK.L) announced that the US Food and Drug Administration has approved Blujepa (gepotidacin) for the treatment of female adults (greater than or equal to 40 kg) and pediatric patients (greater than or equal to 12 years, greater than or equal to40 kg) with uncomplicated urinary tract infections or uUTIs caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.
US commercial launch is planned in the second-half of 2025.
Uncomplicated urinary tract infections are the most common infection in women, impacting up to 16 million women in the US annually. Over half of all women are affected by uUTI in their lifetime, with approximately 30% suffering from at least one recurrent episode which can cause significant patient burden, including discomfort and restriction of daily activities.
The approval was based on positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTI, in female adults (?40 kg) and pediatric patients (?12 years, ?40 kg) with a confirmed uUTI.
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