Pyramax®

Shin Poong

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

Therapeutic indication
  • Treatment of uncomplicated malaria caused by P. falciparum or by P. vivax in adults and children ≥20kg

Dosing
  • Once-daily for 3 days

Efficacy
  • 28-day PCR-corrected ACPR* >98%

  • 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
Challenges
  • WHO Information Note of October 2019 now supports use, purchase and inclusion in national guidelines, yet not formally included in WHO Malaria Treatment Guidelines
Status
  • Positive opinion from EMA (Article 58). Cross-listed on WHO list of prequalified medicines. Included in WHO Essential Medicines List (adults and children) and use now supported by WHO Information Note

  •  Included in national treatment guidelines of Cameroon, Côte d’Ivoire, Guinea, Niger, Nigeria and Republic of Congo
     
  •  Approved in 28 countries
Next milestone
  • Inclusion in WHO Malaria Treatment Guidelines

  •  Publication of multi-country phase IIIb/IV “CANTAM” study results
     
  •  Continued commercial introduction in malaria-endemic countries
Previously
  • Development project team led by University of Iowa

MMV Project Director
  • Adam Aspinall

* ACPR = adequate clinical and parasitological response