Artemether-lumefantrine

Novartis
Asexual blood stages
Paediatric formulation
3-day cure, artemisinin-based combination therapies (TPP-1)

Artemether-lumefantrine

Product development
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Patient confirmatory
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