GSK Reports the US FDA’s NDA Acceptance of Gepotidacin with Priority Review to Treat Uncomplicated Urinary Tract Infections
Shots:
- The US FDA has accepted NDA & granted priority review (PDUFA: Mar 26, 2025) to gepotidacin for treating uncomplicated urinary tract infections (uUTIs) in female adults (≥40kg) & adolescents (≥12yrs., ≥40kg)
- NDA submission was based on P-III (EAGLE-2, n=1531; EAGLE-3, n=1605) studies assessing the safety & efficacy of gepotidacin (1,500mg, oral, BID for 5 days) vs nitrofurantoin (100mg, oral, BID for 5 days) to treat uUTIs with the follow-up period of 28 days
- Studies depicted non-inferiority of gepotidacin to nitrofurantoin (SoC for uUTI), with the success rates of 50.6% vs 47% (treatment difference: 4.3%) in EAGLE-2 & 58.5% vs 43.6% (treatment difference: 14.6%) in EAGLE-3
Ref: GSK | Image: GSK
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
