What it is
Coartem® Baby and Pyramax®’s new formulations for children and pregnant women are safe and effective against malaria and better suited to their specific needs.
Why it matters
Malaria is life-threatening for unborn babies and children under five and a leading cause of child mortality in Africa. These safer and more acceptable medicines will better protect children from this threat.
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 over 20 malaria research projects,[2] advancing simpler and improved therapies for children with severe malaria[3] and for pregnant women.[4] Crucially, EDCTP has also contributed to:
- The approval of the antimalarial medicine Pyramax,[5]including reconfirming the safety and efficacy of re-treating with it.[6] It also enabled research on its safety in pregnant women,[7] and facilitated the development of a paediatric formulation[8].
- The update of the regulatory dossier for the antimalarial Eurartesim, supporting its use as a new treatment option for uncomplicated malaria.[9]
- The approval of the first-ever malaria therapy for babies weighing less than 5 kg[10], a priority population for which no approved medicine or vaccine currently existed. A new dissolvable medicine that can be mixed with breast milk, has a sweet cherry flavour to ease administration, and delivers precise dosing, improving safety and therapeutic effectiveness[11].
By advancing malaria treatments suitable for babies and other priority populations, EDCTP helps reduce child mortality and illness, alleviates the long-term burden of malaria on families and communities, and supports Africa’s public health priorities.[12]Global Health EDCTP3 continues to drive innovation against malaria, including supporting new formulations to address drug resistance,[13] protect pregnant women,[14] and improve vector-control tools.[15]
Sources:
[2] Malaria - International partnerships against infectious diseases & 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] European Medicines Agency recommends new malaria treatment for approval | European Medicines Agency (EMA)
[10] First malaria treatment for babies and young infants receives approval - EDCTP
[11] First malaria treatment for babies and young infants receives approval - EDCTP
[12] Africa CDC Applauds First-Ever Malaria Treatment for Infants Under 5 kg – Africa CDC
[13]https://www.edctp.org/news/wanecam-2-consortium-reports-positive-results-from-phase-2b-study-of-novel-treatment-for-children-with-malaria/
[14] Home - SAFIRE - Safety of Antimalarials in FIRst trimEster
[15] Delftia TsuruhatensTC1 Based-Intervention For Interrupting Malaria Transmission In Mosquitoes: A Novel Trial For Evaluating Alternative Tools For Control Of Vector-Borne Diseases | DEFEND | Project | Fact Sheet | HORIZON | CORDIS | European Commission & Effect of long-acting spatial repellents (LASR) vs indoor residual spraying (IRS) on malaria burden in western Kenya: a cluster-randomised trial | LASR | Project | Fact Sheet | HORIZON | CORDIS | European Commission
Related links
New and better medicines already saving and improving lives
RTS,S and R21/Matrix-M are the first vaccines against malaria and, more broadly, against any parasitic disease. Both vaccines stimulate an immune response that prevents malaria infection.
Triomune Baby/Junior became the first fixed-dose combination medicine developed specifically for children with HIV and paved the way for additional improved combination therapies for first- and second-line HIV treatment in children.
This new fixed-dose combination therapy of albendazole/ivermectin targets five types of parasitic worms (four soil-transmitted helminth infections and lymphatic filariasis), which will significantly improve the efficiency and cost-effectiveness of large-scale interventions.
Coartem® Baby and Pyramax®’s new formulations for children and pregnant women are safe and effective against malaria and better suited to their specific needs.
Arpraziquantel is the first child-friendly medicine in an oro-dispersible formulation to treat and cure schistosomiasis. It is easy to administer and adapted for rural and tropical settings, offering high efficacy with minimal side effects.
Fexinidazole is the first all-oral treatment for sleeping sickness. Taken as simple pills over 10 days, it eliminates the need for hospitalisation and painful lumbar punctures, and has become the most widely used therapy for this disease.
This new therapy, a single high-dose of liposomal Amphotericin B, is as effective as the traditional week-long regimen, easier to administer, and causes fewer side effects. It is now the WHO-recommended therapy for cryptococcal meningitis.
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.