Pyramax®

Shin Poong

Product category
  • Artemisinin-based Combination Therapy (ACT)

  • Pyronaridine-artesunate

Therapeutic indication
  • Pyramax tablets: 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 ACT approved by a stringent regulatory authority for both P. falciparum and P. vivax (blood-stage)

  • No food restrictions

Challenges
  • Limited use recommendation by WHO (policy recommendation under review)

Status
  • Positive opinion from EMA (Article 58); new label (tablets) in 2015. Cross-listed on WHO list of prequalified medicines Included in WHO Essential Medicines List (adults and children)

  • Included in national treatment guidelines of Côte d’Ivoire, Niger and Republic of Congo
  • Approved in 25 countries (see map), country launches began in 2018 in sub-Saharan Africa

Next milestone
  • Completion of multi-country Ph IIIb/IV CANTAM study in 2019

  • Commercial introduction in Africa

Previously
  • Development project team led by University of Iowa
MMV Project Director
  • Adam Aspinall

* ACPR = adequate clinical and parasitological response