Eurartesim®

Alfasigma

Product category
  • Artemisinin-based Combination Therapy (ACT)

  • 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 20 countries (see map)

Next milestone
  • Submit application for marketing authorisation for dispersible paediatric formulation to EMA in 2018

  • Cardiac safety and pharmacokinetics study in pregnancy in Tanzania

  • Results from pilot evaluation of efficacy and safety in Mass Drug Administration (MDA) use

MMV Project Director
  • Dr André-Marie Tchouatieu

* ACPR = adequate clinical and parasitological response