GSK Reports the US FDA Approval of Blujepa for Uncomplicated Urogenital Gonorrhoea (uGC)
Shots:
- The US FDA has approved GSK‘s Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uGC caused by Neisseria gonorrhoeae who have limited or no alternative options for treatment
- Approval was backed by P-III (EAGLE-1) trial assessing Blujepa (2 doses × 3000mg; PO) vs ceftriaxone (500mg; IM) + azithromycin (1000mg; PO) in ~600 pts with uGC
- Trial demonstrated non-inferiority to the SoC, along with favorable safety; ; data were presented in ESCMID 2024 & published in The Lancet in Apr 2025
Ref: GSK | Image: GSK |Press Release
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