GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs)
Shots:
- The US FDA has approved Blujepa to treat uUTIs in female adults (≥40kg) & adolescents (≥12yrs., ≥40kg) caused by E. coli, K. pneumoniae, C. freundii complex, S. saprophyticus & E. faecalis; commercially available in H2’25
- Approval was based on P-III (EAGLE-2, n=1531; EAGLE-3, n=1605) studies assessing gepotidacin (1500mg, PO, BID for 5 days) vs nitrofurantoin (100mg, PO, BID for 5 days) to treat uUTIs with the follow-up of 28 days
- Studies depicted non-inferiority of gepotidacin to nitrofurantoin (SoC for uUTI), with the success rates of 50.6% (162/320) vs 47% (135/287; treatment difference: 4.3%) in EAGLE-2 & 58.5% (162/277) vs 43.6% (115/264; treatment difference: 14.6%) in EAGLE-3
Ref: GSK | Image: GSK
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
