Artemether-lumefantrine-amodiaquine FDC

Product development

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Patient confirmatory

Fosun Pharma

Asexual blood stages

3-day cure, artemisinin-based combination therapies (TPP-1)

Product vision	Management of the spread of drug resistant uncomplicated malaria Use in areas at risk of artemisinin resistance to mitigate emergence and spread
Dosing	Co-formulated tablets of artemether (20 mg) - lumefantrine (120 mg) -amodiaquine (40 mg) as a fixed dose combination. Child friendly dispersible taste-masked formulation available 1-6 tablets (5 kg to > 55 kg) twice daily for 3 days
Efficacy	A large, multi-country study demonstrated PCR-corrected Day42 efficacy of triple combination of between 96-100% compared to 36-100% for artemether-lumefantrine alone
Key features	Demonstrated efficacy against Kelch13 partial resistant strains Fixed-dose combination and child friendly formulation have similar pricing
Challenges	Development of fixed dose combination, and comparative efficacy study of triple combination vs artemether-lumefantrine and amodiaquine-artesunate Need for policy endorsement by WHO, national treatment guidelines
Status	DeTACT study ongoing for loose combination Ph III study of co-formulated drug due to start recruitment Q2 2023
Next milestone	Last-Patient-Last-Visit for ongoing study in 2023
Project Director	Adam Aspinall