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GSK uUTI treatment approved by US FDA
GSK uUTI treatment approved by US FDA.
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[{"type":"text","content":"\n\nIssued: 25 March 2025, London UK\n \nBlujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients 12 years of age and older\n \n· Blujepa is the first in a new class of oral antibiotics for uUTIs in nearly 30 years\n· Over half of all women experience a uUTI in their lifetime, with approximately 30% suffering from a recurrent episode\n· Approval based on data from the pivotal phase III EAGLE-2 and EAGLE-3 trials\n \n \n \n\nGSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.\n \nDiscovered by GSK scientists, Blujepa is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK's infectious diseases portfolio.\n \nTony Wood, Chief Scientific Officer, GSK, said: \"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.\"[1][2][3][4]\n \nuUTIs are the most common infection in women, impacting up to 16 million women in the US annually.1-4 Over half of all women are affected by uUTI in their lifetime,[5] with approximately 30% suffering from at least one recurrent episode which can cause significant patient burden, including discomfort and restriction of daily activities.[6] New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing which can result in higher treatment failure rates.[7]\n \nThomas Hooton, MD, Professor of Clinical Medicine, University of Miami School of Medicine said: \"For many, uUTIs can be a burden that severely impacts daily life. With an increasing number of patients experiencing recurrent infections, there remains a c...