Artesunate for Injection

Ipca

Product category
  • Artesunate for injection

Therapeutic indication
  • Treatment of severe malaria caused by the parasite P. falciparum, to be followed by a full course of ACT

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

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

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

  • Pharmacovigilance conducted in collaboration with African Collaboration Center proved that injectable artesunate has a favorable safety profile

Key features
  • Addressing supply challenges

Challenges
  • Potential for delayed haemolytic anaemia

Status
  • Submitted for WHO Prequalified

  • Registration variation approvals expected in >6 countries in 2018

Next milestone
  • Simplified injectable artesunate (two vial system) to be developed for WHO prequalification review before 2020