Artemether-lumefantrine <5 kg

Product development

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Patient confirmatory

Novartis

Asexual blood stages

Paediatric formulation

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

Product vision	3-day cure, artemisinin-based combination therapy for patients <5 kg
Therapeutic indication	First antimalarial for treatment of neonates and infants <5 kg with uncomplicated P. falciparum infection
Dosing	Twice-daily for 3 days
Efficacy	Under investigation, yet expected to be the same as in adult and children >5 kg population
Key features	New dispersible tablet with optimized artemether:lumefantrine ratio to provide appropriate exposure in the neonate and infant population
Status	Pharmacokinetic /pharmacodynamic (PK/PD) bridging registration study started in Africa
Next milestone	Pharmacokinetic/pharmacodynamic (PK/PD) bridging registration study completion
Project Director	Yveline Angeville