| Product vision |
- Product indicated for prevention of relapse for P. vivax
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| Therapeutic indication |
- Use in combination with chloroquine (CQ) for the prevention of relapse of P. vivax malaria from 2 years of age
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| Dosing |
- For adults/adolescents/children 35 kg and above: single dose 300 mg (2 x 150 mg tabs)
- For children >2 years and until 35 kg: 50 mg dispersible tablets; weight-based dosing
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| Efficacy |
- Phase III data confirms 62% (95% confidence interval: 55%; 69%) recurrence-free efficacy (relapses + new infections) at 6 months post treatment when used with CQ
- Paediatric pharmacokinetic bridging study shows relapse-free efficacy rate at 4 months of 95% (95% confidence interval: 85%; 98%) in children from 2 to <16 years of age
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| Key features |
- Single-dose treatment to prevent relapse of P. vivax malaria
- Shelf life: 5 years for TQ 150 mg tablets (varies by country); 2-years for TQ 50 mg dispersible tablets
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| Challenges |
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Quantitative testing for glucose-6-phosphate dehydrogenase (G6PD) deficiency required, as product is contraindicated in patients with G6PD deficiency
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No data available to support TQ use with ACTs for prevention of P. vivax relapse
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| Status |
- 150 mg tablet approved by US FDA (July 2018), by Australian TGA (Sept 2018), Brazil (Oct 2019), Thailand (Dec 2019), Peru (Jan 2021), Colombia (July 2022) and the Philippines (Nov 2022)
- Under review in 4 endemic countries including 2 following subsequent ASEAN joint assessment procedure review
- Pediatric dispersible tablets approved by the Australian TGA (March 2022) and under review by ANVISA (Brazil), DIGEMID (Peru), and INVIMA (Colombia)
- Feasibility studies recruitment: TRuST (Brazil): completed; ARCTIC (Thailand): ongoing
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| Next milestone |
- INSPECTOR study PK results awaited (expected Q2 23)
- •Feasibility studies: TRuST: Final analysis (April 2023); ARCTIC: 1st interim analysis (2022), Final (2023); Peru FPFV: Q3 2023; Ethiopia FPFV: Q4 2023; Vietnam FPFV: Q1 2024
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| Project Director |
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