Tafenoquine paediatric

GSK

Product vision
  • Product targeting prevention of relapse for P. vivax
Dosing
  • Single-dose treatment in children 2 years and older who cannot take the adult tablet 
  • 50 mg 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 <16 years of age
Key features
  • Single-dose treatment to prevent relapse of P. vivax malaria
Challenges
  • Quantitative testing for glucose-6-phosphate dehydrogenase (G6PD)deficiency required, as product is contraindicated in patients with G6PD deficiency
  • Not for use in combination with ACTs for the prevention of relapse of P. vivax
Status
  • Marketing authorization application (MAA) variation/line extension approved by the Australian Therapeutic Goods Administration (TGA) in March 2022 and under review by ANVISA (Brazilian Health Regulatory Agency)
Next milestone
  • MAA submissions in additional P. vivax endemic countries
MMV Project Director
  • Dr Elodie Jambert