Pyramax® Granules becomes first paediatric antimalarial to receive EMA Article 58 positive scientific opinion

EMA opinion will facilitate the new medicine’s use in malaria-endemic countries

20 Nov 2015

Pyramax® Granules, the child-friendly fixed-dose artemisinin combination therapy (ACT) of pyronaridine and artesunate, becomes 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. falciparum and P. vivax.

“Around 78% of people dying from malaria are children less than 5 years of age,” said David Reddy, MMV’s CEO. “The timely development of age-appropriate formulations to address the needs of this particularly vulnerable population is essential. Following this positive scientific opinion from EMA, MMV, Shin Poong and other partners can work with endemic countries to pursue national approvals for Pyramax Granules and make the medicine available to children in need.”  

Pyramax Granules and the tablet formulation Pyramax® (for adults and children weighing >20kg) were developed by the product development partnership Medicines for Malaria Venture (MMV) and Shin Poong Pharmaceutical Co. Ltd., Republic of Korea. The partnership has taken the drug combination through pre-clinical studies and early clinical studies leading to four successful, pivotal Phase III clinical trials with over 3,500 patients in 18 countries in sub-Saharan Africa, Southeast Asia and India and a large Phase IIIb/IV safety and efficacy study with patients from Mali, Burkina Faso and Guinea. The Phase IIIb/IV study was led by the West African Network for Clinical Trials of Antimalarial Drugs (WANECAM) with funding from the European & Developing Countries Clinical Trials Partnership (EDCTP) and MMV.

In parallel with the introduction of Pyramax Granules in endemic countries, MMV and Shin Poong will work with partners to conduct a Phase IV pharmacovigilance study to generate further data about Pyramax tablets and Pyramax Granules in real-life settings.

“We are proud to have reached this landmark achievement with our long-standing partner Medicines for Malaria Venture,” said Jei Man Ryu, CEO of Shin Poong Pharmaceutical. “We have worked with dedication to achieve this goal and will continue to collaborate with MMV to ensure that this important life-saving medicine reaches the children for whom we developed it. Unacceptable numbers of children continue to die of malaria and this medicine will be of enormous benefit to those children suffering from either P. vivax or P. falciparum blood-stage malaria.”