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
  • Ongoing medical education engagement with technical working groups to support national policy review in multiple African countries

  • Included in WHO Essential Medicines List (adults and children)

  • Inclusion in medical treatment policy in Ivory Coast in November 2018

  • Approved in 12 countries (see map)

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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