Blujepa FDA Approval History
Last updated by Judith Stewart, BPharm on March 25, 2025.
FDA Approved: Yes (First approved March 25, 2025)
Brand name: Blujepa
Generic name: gepotidacin
Dosage form: Tablets
Company: GlaxoSmithKline
Treatment for: Urinary Tract Infection
Blujepa (gepotidacin) is a triazaacenaphthylene bacterial type II topoisomerase inhibitor used for the treatment of uncomplicated urinary tract infections.
- Blujepa is indicated for the treatment of female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg) with uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of Blujepa and other antibacterial drugs, Blujepa should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. - An uncomplicated urinary tract infection (also known as cystitis or lower tract UTI) is a bacterial infection of the bladder and associated structures in patients without comorbidities such as diabetes, patients who are immunocompromised, those who have had recent urologic surgery, or those who are pregnant.
- Blujepa contains gepotidacin, a first-in-class triazaacenaphthylene antibiotic that works to provide activity against most target uropathogens by inhibiting bacterial DNA replication through the inhibition of type II topoisomerase enzymes (bacterial topoisomerase II (DNA gyrase) and topoisomerase IV).
- FDA approval of Blujepa was based on positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority to nitrofurantoin.
- In EAGLE-2, Blujepa demonstrated non-inferiority in therapeutic success which occurred in 50.6% (162/320) of participants compared to 47.0% (135/287) for nitrofurantoin (covariate-adjusted treatment difference 4.3%, 95% CI (-3.6, 12.1)).
- In EAGLE-3, Blujepa demonstrated statistically significant superiority versus nitrofurantoin (one-sided p-value 0.0003). Therapeutic success occurred in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin (covariate-adjusted treatment difference 14.6%, 95% CI (6.4, 22.8)). - Blujepa tablets are administered orally, twice daily after a meal (approximately 12 hours apart), for 5 days.
- Warnings and precautions associated with Blujepa include QTc prolongation (avoid use in patients with a history of QTc prolongation and patients receiving drugs that prolong the QTc interval), acetylcholinesterase inhibition (monitor patients with underlying medical conditions), hypersensitivity reactions including anaphylaxis, and Clostridioides difficile infection.
- Common adverse reactions (≥1% of patients) include diarrhea, nausea, abdominal pain, flatulence, headache, soft feces, dizziness, vomiting, and vulvovaginal candidiasis.
- The efficacy and safety of gepotidacin is also being evaluated in phase III clinical trials for the treatment of urogenital gonorrhoea.
Development timeline for Blujepa
Further information
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