GSK’s Blujepa (gepotidacin) has received FDA approval for the treatment of uncomplicated urinary tract infections (uUTIs) in females aged 12 and above (≥40 kg). This marks the first approval in a new class of oral antibiotics for uUTIs in nearly three decades, targeting an urgent public health need amidst rising antimicrobial resistance.
Key Highlights:
- First-in-Class Antibiotic:
Blujepa is a triazaacenaphthylene antibiotic with a novel mechanism of inhibiting bacterial DNA replication by targeting two Type II topoisomerases.
Active against E. coli, Klebsiella, Staphylococcus saprophyticus, and drug-resistant N. gonorrhoeae.
- FDA Approval Based on EAGLE-2 & EAGLE-3 Trials:
EAGLE-2: Non-inferior to nitrofurantoin (50.6% vs. 47.0% therapeutic success).
EAGLE-3: Showed statistically significant superiority (58.5% vs. 43.6%) over nitrofurantoin.
Administered as 1500 mg orally twice daily for five days.
"Blujepa is a crucial milestone… the first in a new class of oral antibiotics for uUTIs in nearly three decades."Tony Wood, Chief Scientific Officer, GSK
- Patient Impact : Over 50% of women will experience a uUTI in their lifetime. 30% suffer from recurrent episodes, leading to discomfort and lifestyle restrictions. Blujepa is positioned as a critical solution for drug-resistant uUTIs.
- Safety Profile:
Well-tolerated overall.
Most common adverse events were gastrointestinal (diarrhea 16%, nausea 9%).
Majority were mild to moderate; <1% experienced severe GI symptoms.
Full prescribing info available here.
