Shots:
- The US FDA has accepted sNDA & granted priority review to Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uncomplicated urogenital gonorrhoea (PDUFA: Dec 11, 2025); regulatory review is ongoing in the UK & Australia
- sNDA 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 uncomplicated urogenital gonorrhoea; data were presented in ESCMID 2024 & published in The Lancet
- Trial demonstrated non-inferiority, with urogenital site success rates of 92.6% (187/202) vs 91.2% (186/204), & no failures in either arm due to bacterial persistence of N. gonorrhoeae
Ref: GSK | Image: GSK | Press Release
Related News:- GSK Enters a ~$12.5B Deal with Hengrui Pharma to Develop up to 12 Novel Therapeutics Across Various Indications
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