Artesunate for Injection

Ipca

Legend
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 Prequalification

  • 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