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