Blujepa (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

The FDA has approved Blujepa (gepotidacin) for treating uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients. The FDA approved Blujepa based on positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials, which demonstrated non-inferiority to nitrofurantoin. The drug’s safety and tolerability profile was consistent with previous trials, with the most common adverse events being gastrointestinal (GI) reactions. The US commercial launch is planned in 2H 2025. Blujepa is part of GSK’s infectious diseases portfolio and aims to address recurrent infections and rising rates of resistance to existing treatments.