ArtesunĀ®

Guilin Pharmaceutical

Product category
  • Artesunate for injection

Therapeutic indication
  • Treatment of severe malaria caused by the parasite P. falciparum, to be followed by oral medication

Dosing
  • Intravenous or intramuscular injection for at least 1 day during critical phase (30mg, 60mg, 120mg)

     

Efficacy
  • 92% survival vs 88% survival with quinine in African children

  • Coma scores, convulsions, and hypoglycaemia significantly less frequent with artesunate compared to quinine 

  • PV conducted in collaboration with African Collaboration Center proved that Inj AS has a favorable safety profile

Key features
  • The sole WHO-prequalified injectable artesunate

     

Challenges
  • Concern from disease-endemic countries regarding single-source supply

  • Potential for delayed haemolytic anaemia

Status
  • WHO prequalification 2010

  • Approved in 34 countries (see map); 100 million vials shipped since prequalification

Next milestone
  •  Simplified Inj AS two vial to be developed for WHO PQ review before 2020

 

MMV Project Director
  • Pierre Hugo