What it is
Pyramax® is an established antimalarial medicine whose safety and efficacy have been progressively expanded through EDCTP-supported research to reach more patient groups who lack specific treatment options, including children, pregnant women and patients requiring re-treatment.
Why it matters
Malaria is a leading cause of child mortality in Africa, yet treatment options remain insufficient for some priority populations. Extending the use of existing medicines to groups often under-represented in clinical research can be as important as developing entirely new treatments. By supporting the generation of this evidence, EDCTP has helped ensure that more people can access safe, effective treatment.
The story
Each year, malaria affects more than 250 million people and causes over half a million deaths, the majority among children under five.[1] Since 2003, EDCTP has supported more than 20 malaria research projects,[2] advancing simpler and improved therapies for children with severe malaria[3] and for pregnant women.[4]
EDCTP-supported research has contributed to broadening the reach of Pyramax® (pyronaridine tetraphosphate and artesunate), a fixed-dose artemisinin-based combination therapy used to treat uncomplicated malaria caused by Plasmodium falciparum and Plasmodium vivax.
In 2012, the European Medicines Agency (EMA) issued a positive scientific opinion on Pyramax® under its Article 58 procedure. This procedure allows the EMA to provide a scientific opinion on medicines intended exclusively for markets outside the European Union, in cooperation with WHO.[5] The opinion supported the use of Pyramax® for uncomplicated malaria and helped facilitate its subsequent WHO prequalification and wider access.[5]
However, important evidence gaps remained. In particular, there was limited evidence on whether Pyramax® could be safely used to treat recurrent malaria infections and whether it could be used safely in pregnant women and young children.
EDCTP-supported research helped address these gaps. The WANECAM study provided evidence supporting the safety and efficacy of re-treating malaria with Pyramax®,[6] while research contributed to the inclusion of information on its use in pregnant women in the product label.[7] EDCTP-supported work also contributed to the development and evaluation of a paediatric formulation, helping extend access to children who need age-appropriate treatment.[8]
Global Health EDCTP3 continues to support innovation against malaria, including research into new treatments and formulations to address drug resistance,[9] improve treatment options for pregnant women,[10] and strengthen vector-control tools.[11]
Affordable access
Through the Global Fund’s Pooled Procurement Mechanism, Pyramax® is available at US$0.40-1.20 per treatment for the oral granule formulation (for patients weighing 5-20 kg) and US$0.58-2.32 per treatment for the tablet formulation (for patients weighing 20 kg or more), depending on body weight. These prices are generally higher than those of widely used artemether-lumefantrine treatments, in some cases costing around two to four times more.[12] This price difference limits how widely resource-constrained malaria programmes can procure and use Pyramax®.
Sources:
[2] Malaria – International partnerships against infectious diseases | EDCTP & Malaria treatment | EDCTP
[3] Simplified artesunate regimen found efficacious in treating children with severe malaria | EDCTP
[4] PREGACT: Safety and efficacy of four artemisinin-based combination treatments in African pregnant women with malaria | EDCTP
[5] Pyramax – opinion on medicine for use outside EU | European Medicines Agency (EMA)
[6] Re-treating malaria with Pyramax®: WANECAM study supports safety and efficacy | EDCTP
[7] Pyramax® label update: Now includes information for the treatment of pregnant women with malaria | Medicines for Malaria Venture
[8] Pyramax® approved as antimalarial for treatment of multiple episodes of malaria | EDCTP
[9] WANECAM-2 consortium reports positive results from phase 2b study of novel treatment for children with malaria | EDCTP
[10] SAFIRE Consortium - Safety of Antimalarials in FIRst trimEster | SAFIRE
[11] DEFEND project | Global Health EDCTP3 & LASR project | Global Health EDCTP3
[12] Pooled Procurement Mechanism Reference Pricing: Antimalarial medicines | The Global Fund
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Pyramax® is an established antimalarial medicine whose safety and efficacy have been progressively expanded through EDCTP-supported research to reach more patient groups who lack specific treatment options, including children, pregnant women and patients requiring re-treatment.
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Our added value for Europe
EDCTP boosts Europe’s competitiveness by advancing research excellence, innovation, and public–private cooperation in global health. By supporting late-stage development and Africa–Europe partnerships, it bridges the EU innovation gap and creates new market and investment opportunities.
EDCTP strengthens Europe’s health security by tackling climate-sensitive diseases and antimicrobial resistance, enhancing surveillance, and accelerating medical countermeasures. Its rapid crisis responses, from Ebola to COVID-19, show its agility in protecting Europe and global health.
EDCTP drives Europe’s science diplomacy through fair Africa–Europe partnerships that tackle global health challenges. Its equitable governance and ethical research practices strengthen EU credibility and global influence.
EDCTP strengthens Europe’s leadership in digital health by investing in AI, data, and digital technologies while training researchers in fields like bioinformatics and genomic epidemiology.
EDCTP advances the EU’s human rights goals by promoting ethical, inclusive research that addresses unmet medical needs. It ensures innovations reach vulnerable populations while strengthening local scientific and health systems.
Our added value for Africa
EDCTP improves health and prosperity in Africa by funding clinical research, strengthening local capacities, and empowering African scientists. Its investments reduce the burden of infectious diseases, boost productivity, and support sustainable development across the continent.
EDCTP builds Africa’s capacity to detect, prevent, and respond to outbreaks through training, research, and strong partnerships. Its work accelerates vaccine and diagnostic development and reinforces the continent’s health resilience.
EDCTP strengthens Africa’s clinical research ecosystem by investing in skills, infrastructure, and regulatory systems. Initiatives like CTCAN and PACTR connect researchers and regulators, expanding quality trials and fostering local leadership.
EDCTP strengthens Africa-led health partnerships with organisations like Africa CDC and WHO AFRO, aligning research and investment with continental priorities. As an AU–EU Innovation Agenda partner, it builds skills, fosters co-investment, and drives sustainable cooperation.
EDCTP promotes health equity by developing practical solutions for underserved communities, including newborns and children, women, urban poor and rural communities. It funds accessible technologies and digital tools that expand healthcare reach and improve outcomes for those most in need.