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