On 24 April 2026, the World Health Organization (WHO) prequalified Coartem® (artemether-lumefantrine) Baby, the first and only antimalarial developed specifically for newborns and young infants weighing from 2 to 5 kilograms.
The treatment was developed with support from EDCTP2, the predecessor programme to Global Health EDCTP3, marking a major milestone in closing a long-standing treatment gap affecting some 30 million babies born each year in malaria-endemic areas of Africa.
The WHO prequalification ensures the treatment meets international standards of quality, safety and efficacy. It will enable global health procurers to include the treatment in their programmes and facilitate broader access to this vulnerable population.
Addressing a critical gap in malaria treatment
For decades, clinicians have faced the critical challenge of treating malaria in the smallest infants without medicines specifically tested or designed for them. In many cases, infants with malaria were treated with formulations intended for older children, increasing the risk of dosing errors, side effects and toxicity.
This new treatment, also known as Riamet® Baby in some countries, is a dispersible formulation with a sweet cherry flavour designed to ease administration in newborns and enable precise dosing. It is tailored to very low body weight, improving both safety and treatment effectiveness.
'Coartem® Baby is a clear example of what long-term, coordinated investment in health research can achieve. Through Europe-Africa partnerships, we are strengthening health systems and improving health outcomes in Africa, while simultaneously reinforcing Europe’s competitiveness.
By working with a global network of partners, we are able to drive scientific progress and develop innovations that respond to long-standing unmet medical needs of the most vulnerable populations.'
Michael Makanga, Executive Director, Global Health EDCTP3
Coartem® Baby was developed by Novartis and the Medicines for Malaria Venture, with co-funding from the European & Developing Countries Clinical Trials Partnership 2 (EDCTP2) and the Swedish International Developement Agency through the PAMAfrica consortium. Between 2020 and 2024, the PAMAfrica consortium conducted the CALINA trial across Burkina Faso, the Democratic Republic of Congo, Kenya, Mali, Nigeria and Zambia to evaluate the treatment’s effectiveness and safety.
The results showed that Coartem® Baby achieved therapeutic drug levels in the bloodstream comparable to those observed in older children, supporting effective parasite clearance, while also generating key additional safety data.
The trial contributed to the market authorisation by Swissmedic for this formulation in July 2025, ensuring that the new treatment is both efficacious and safe for use in young children.
Details
- Publication date
- 29 April 2026
- Author
- Global Health EDCTP3 Joint Undertaking