Product vision |
|
Dosing |
|
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 |
|