Pyramax® Granules received positive scientific opinion from the European Medicines Agency

Pyramax® Granules, the child-friendly fixed-dose artemisinin combination therapy (ACT) of pyronaridine and artesunate is the first paediatric antimalarial to be granted a positive scientific opinion from the European Medicines Agency (EMA) under Article 58. Article 58 was established to enable the EMA to undertake a scientific assessment and provide guidance, in cooperation with the World Health Organization (WHO), on products that are not intended for use in Europe, thereby providing a valuable service for the wider global health community. The Pyramax Granules opinion will support the registration and use of this new medicine for young children in malaria-endemic countries.

Adapted to the needs of children, Pyramax Granules is taste-masked, suspends in approximately two teaspoons of liquid, and is taken once-daily for 3 days with or without food. This formulation is well suited to sick children, who need to take the full dose in order to achieve complete cure. Pyramax Granules is also the first paediatric medicine to be indicated for the treatment of acute, uncomplicated blood-stage malaria caused by either of the two main species of parasite, P. falciparumand P. vivax.

Pyramax Granules and the tablet formulation Pyramax (for adults and children weighing >20kg) were co-developed by MMV and Shin Poong Pharmaceutical Co. Ltd., Republic of Korea. After a limited EMA Article 58 positive opinion was granted in 2012, Pyramax was studied in a Phase IIIB/IV safety and efficacy study in West Africa (WANECAM)1 over two years. The interim results of this study, published in The Lancet Infectious Diseases2, evaluated the safety and efficacy of Pyramax when administered to patients in the study each time they suffered repeated bouts of malaria over the 2 year period. The results of the study indicate that the safety profile of Pyramax is similar with retreatment versus with initial treatment.

Today, both Pyramax tablets and granules appear on the WHO’s list of prequalified medicines, enabling them to be purchased with donor funds.

1. Pan African Clinical Trials Registry 

2. Sagara, Issaka et al, Safety and efficacy of re-treatments with pyronaridine-artesunate in African patients with malaria: a substudy of the WANECAM randomised trial. The Lancet Infectious Diseases , Volume 16 , Issue 2 , 189 – 198. doi:10.1016/S1473-3099(15)00318-7.