Tafenoquine paediatric

Tafenoquine paediatric

Access
-
Approved
Tafenoquine
GSK
Relapse prevention
Paediatric formulation
Prevention of relapse for P. vivax (TPP-1)
Product vision
  • Product targeting prevention of relapse for P. vivax

Dosing
  • For adults/adolescents/children 35 kg and above: single dose 300 mg (2 x 150 mg tabs) 
  • For children >2 years and until 35 kg: 50 mg dispersible tablets; weight-based dosing 
Efficacy
  • Phase III data confirms 62% (95% confidence interval: 55%; 69%) recurrence-free efficacy (relapses + new infections) at 6 months post treatment when used with CQ
  • Paediatric pharmacokinetic bridging study shows relapse-free efficacy rate at 4 months of 95% (95% confidence interval: 85%; 98%) in children from 2 to <16 years of age
Key features
  • Single-dose treatment to prevent relapse of P. vivax malaria
  • Shelf life: 5 years for TQ 150 mg tablets (varies by country); 2-years for TQ 50 mg dispersible tablets
Challenges
  • Quantitative testing for glucose-6-phosphate dehydrogenase (G6PD)  deficiency required, as product is contraindicated in patients with G6PD deficiency
  • No data available to support TQ use with ACTs for prevention of P. vivax relapse
Status
  • 150 mg tablet approved by US FDA (July 2018), by Australian TGA (Sept 2018), Brazil (Oct 2019), Thailand (Dec 2019), Peru (Jan 2021) and Colombia (July 2022)
  • Under review in 5 endemic countries including 3 following subsequent ASEAN joint assessment procedure review
  • Pediatric dispersible tablets approved by the Australian TGA (March 2022) and under review by ANVISA (Brazil), DIGEMID (Peru), and INVIMA (Colombia)
  • Feasibility studies recruitment: TRuST (Brazil): completed; ARCTIC (Thailand): ongoing 
Next milestone
  • INSPECTOR study PK results awaited (expected Q2 23)
  • Feasibility studies: TRuST: 2nd interim analysis (mid-Nov 2022); Final (2023); ARCTIC: 1st interim analysis (2022), Final (2023)
Project Director
  • Dr Elodie Jambert