FDA Approves GSK’s Blujepa (gepotidacin) for Urinary Tract Infections

GSK has announced that the U.S. Food and Drug Administration (FDA) has approved Blujepa (gepotidacin), a first-in-class oral antibiotic, for treating uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients aged 12 and above. This marks the first new class of oral antibiotics for uUTIs in nearly 30 years.

Chief Scientific Officer Tony Wood highlighted the drug’s significance, noting rising antibiotic resistance and recurrent infections among patients. The approval follows successful Phase III trials (EAGLE-2 and EAGLE-3), where Blujepa demonstrated strong efficacy against Escherichia coli, Klebsiella pneumoniae, and other common uropathogens.

Blujepa is a novel antibiotic that inhibits bacterial DNA replication through a unique mechanism, reducing the likelihood of resistance development. It has shown effectiveness in treating uUTIs, including cases caused by drug-resistant bacteria.

With uUTIs affecting up to 16 million women annually in the U.S., experts stress the need for new treatments. The commercial launch of Blujepa is planned for the second half of 2025. The drug's development was partly funded by U.S. government agencies.

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