Eurartesim®

Alfasigma

Product category
  • 3-day cure, artemisinin-based combination therapy (dihydroartemisinin-piperaquine)

Therapeutic indication
  • Treatment of uncomplicated P. falciparum malaria in adults, children and infants >5kg

Dosing
  • Once-daily for 3 days

Efficacy
  • 28-day PCR-corrected ACPR* 94.7–99.9%
  • 42-day PCR-corrected ACPR* 91.5–99.3%
Key features
  • Comparatively long post-treatment protection

Challenges
  • EMA cardiac monitoring guidance
  • Confirmed piperaquine resistance in Greater Mekong Subregion (GMS)
Status
  • First stringent regulatory approval EMA 2011
  • Approvals in 24 countries
Next milestone
  • Submit application for marketing authorisation for dispersible paediatric formulation to EMA
  • Complete cardiac safety and pharmacokinetics study in pregnancy in Tanzania
MMV Project Director
  • Anthony Okoth

* ACPR = adequate clinical and parasitological response