| Product vision |
- Product indicated for prevention of relapse for P. vivax
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| Therapeutic indication |
- Use in combination with chloroquine 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 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) and Colombia (July 2022)
- Under review in 5 endemic countries including 3 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: 2nd interim analysis (mid-Nov 2022); Final (2023); ARCTIC: 1st interim analysis (2022), Final (2023)
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| Project Director |
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