By Samira Larbie, GNA
Accra, April 30, GNA – The World Health Organization (WHO) has pre‑qualified Coartem® Baby, the first antimalarial medicine developed specifically for newborns and infants weighing between two and five kilograms.
A statement issued and copied to the Ghana News Agency said the decision, announced on April 24, marked a breakthrough in closing a long‑standing treatment gap affecting millions of infants in malaria‑endemic regions, particularly in Africa.
Mr. Michael Makanga, Executive Director of Global Health EDCTP3, described the development as a milestone in global health research.
“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,” he said.
The new formulation, also known as Riamet® Baby in some countries, was developed by Novartis in collaboration with the Medicines for Malaria Venture, with co‑funding from EDCTP2 and the Swedish International Development Agency.
It is designed as a dispersible tablet with a sweet cherry flavour to ease administration and ensure accurate dosing for very small infants.
Health experts say the WHO prequalification confirms the medicine meets international standards of quality, safety and efficacy, paving the way for global procurement agencies to include it in malaria treatment programmes.
For decades, clinicians have struggled to treat malaria in newborns due to the absence of medicines tailored to their needs.
Infants were often given formulations intended for older children, raising risks of incorrect dosing, side effects, and toxicity.
Between 2020 and 2024, the PAMAfrica consortium conducted the CALINA trial across several African countries, including Burkina Faso, the Democratic Republic of Congo, Kenya, Mali, Nigeria and Zambia.
The study showed the medicine achieved effective drug levels comparable to those in older children, while maintaining a strong safety profile.
The findings supported its market authorisation by Swissmedic in July 2025. Global Health EDCTP3, a Europe‑Africa partnership backed by the European Union and more than 40 countries, continues to support research into infectious diseases affecting sub‑Saharan Africa, with a focus on translating scientific innovation into practical health solutions.
The introduction of Coartem® Baby is expected to improve survival rates and treatment outcomes among one of the most vulnerable patient groups in malaria‑endemic regions.
GNA
Edited by Kenneth Sackey