Paediatric formulations

Developing new products for vulnerable populations

Children

MMV has long recognized that developing better medicines for children helps address the most vulnerable patient population at greatest risk of dying from malaria. MMV and partners are developing and improving access to child-friendly formulations of existing antimalarials for treatment (artemisinin-based combination therapies; ACTs), and chemoprevention (sulfadoxine-pyrimethamine + amodiaquine; SP+AQ), as well as developing next-generation medicines for children in parallel with adult formulations.

Pyramax® granules

Shin Poong

Product category

  • Artemisinin-based Combination Therapy (ACT)

  • Pyronaridine-artesunate
Therapeutic indication

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

  • No food restrictions

  • Child-friendly granules
Challenges

  • Limited use recommendation by WHO (policy recommendation under review)
Status
  • 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 15 countries (see map), country launches began in 2018 in sub-Saharan Africa 
Next milestone
  • National registrations
  • Completion of multi-country Ph IIIb/IV CANTAM study expected by H2/2019
  • Commercial introduction in Africa
Previously

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

* ACPR = adequate clinical and parasitological response 

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