Artemether-lumefantrine

Novartis

Product vision
  • 3-day cure, artemisinin-based combination therapy (artemether-lumefantrine)
Therapeutic indication
  • First antimalarial for treatment of neonates and infants <5kg with uncomplicated P. falciparum infection
Dosing
  • Twice-daily for 3 days
Efficacy
  • Expected to be the same as in adult and children >6months population
Key features
  • New dispersible tablet with specific (1:12) artemether:lumefantrine ratio to provide appropriate exposure in the neonate and infant population
Challenges
  • Recruitment due to target population
Status
  • Application for pharmacokinetic bridging registration study submitted to local ethics committees and health authorities
Next milestone
  • Study start (include first patient) in pharmacokinetic bridging registration study
MMV Project Director
  • Dr Gonzalo Acuña