Tafenoquine paediatric

GSK

Product vision
  • Product targeting prevention of relapse for P. vivax
  •  Uncomplicated malaria treatment for single-exposure radical cure (SERC) and/or resistance management
Dosing
  • Single-dose treatment in children who cannot take the adult tablet
  • Child-friendly dispersible tablet formulation. Dosing scheme maintains target exposure in all weight bands
Efficacy
  • Efficacy in adults established when used with chloroquine
  •  Paediatric pharmacokinetic bridging study shows relapse-free efficacy rate at 4 months of 95% (95% confidence interval: 85%; 98%) in children less than 16 years of age
Key features
  • Single-dose treatment to prevent relapse of P. vivax malaria
  • Contraindicated in glucose-6-phosphate dehydrogenase (G6PD) deficiency
Challenges
  • Quantitative testing for G6PD deficiency required

  • No quantitative G6PD test has been prequalified or approved by a stringent regulatory agency yet
Status
  • Paediatric pharmacokinetics bridging study report in finalization
Next milestone
  • Submission of paediatric marketing authorization application to Australian Therapeutic Goods Administration (TGA)
MMV Project Director
  • Dr Isabelle Borghini