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 acute, 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 for both P. falciparum and P. vivax (blood-stage)

  • No food restrictions

  • Child-friendly granules, once-daily for three days

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

  • Positive opinion from EMA (Article 58) for Pyramax granules in 2015. Cross-listed on WHO prequalification medicines web site

  • Multi-country Ph IIIb/IV study initiated June 2017

  • Included in WHO Essential Medicines List for children

  • Approved in 7 countries (see map)

Next milestone
  • National registrations

  • Commercial introduction in Africa from Q2 2018

Previously
  • Development project team led by University of Iowa

MMV Project Director
  • Adam Aspinall
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