FDA Approval

$GSK

• Approval Announcement: GSK’s Blujepa (gepotidacin) is FDA-approved for treating uncomplicated urinary tract infections (uUTIs) in women and adolescents aged 12+.
• Significance: This marks the first new oral antibiotic class for uUTIs in nearly 30 years, addressing a significant patient need as uUTIs affect over half of women.
• Trial Results: Success demonstrated in EAGLE-2 and EAGLE-3 trials, showing Blujepa was non-inferior to nitrofurantoin with therapeutic success rates of 50.6% and 58.5% versus 47.0% and 43.6%, respectively.
• Safety Profile: Most common adverse events included gastrointestinal issues; serious adverse events were rare.
• Launch Timeline: Planned US commercial launch in the second half of 2025.

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