Pyramax® granules

Shin Poong

Product category
  • 3-day cure, artemisinin-based combination therapy (pyronaridine-artesunate)

Therapeutic indication
  • For the treatment of uncomplicated malaria infection caused by P. falciparum or P. vivax in children and infants weighing 5kg to under 20kg

Dosing
  • Once-daily for 3 days

Efficacy
  • 28-day PCR-corrected ACPR* >97%

  • 42-day PCR-corrected ACPR* 90%–95%

Key features
  • Only artemisinin-based combination therapy approved by a stringent regulatory authority for both P. falciparum and P. vivax (blood-stage)
  • No food restrictions
  • Two-year shelf life
  • Child-friendly granules
Challenges
  • Country order fulfilment by major procurement bodies
Status
  • Included in WHO Essential Medicines List for children. Positive opinion from EMA (Article 58). Cross-listed on WHO list of prequalified medicines. WHO Guidelines for Malaria now consider pyronaridine-artesunate to be a safe and efficacious treatment for uncomplicated malaria.
  • Approved in 19 countries
  • Included in 9 national treatment guidelines
Next milestone
  • Inclusion in WHO Malaria Treatment Guidelines
  • Continued commercial introduction in malaria-endemic countries
  • Approval of 30-month shelf life
Previously
  • Development project team led by University of Iowa

MMV Project Director
  • Adam Aspinall

* ACPR = adequate clinical and parasitological response