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