Geneva: The World Health Organization (WHO) has prequalified Coartem® Baby, marking a significant advancement as the first antimalarial medicine specifically developed for newborns and infants weighing between two and five kilograms.
According to Ghana News Agency, the announcement made on April 24 represents a breakthrough in addressing a longstanding treatment gap impacting millions of infants in malaria-endemic regions, especially in Africa. Mr. Michael Makanga, Executive Director of Global Health EDCTP3, hailed this development as a milestone in global health research, emphasizing the importance of long-term, coordinated investment in health research. He noted that partnerships between Europe and Africa are playing a crucial role in strengthening health systems and improving health outcomes on the continent.
The new medication, also known as Riamet® Baby in some countries, is a result of a collaboration between Novartis and the Medicines for Malaria Venture, with co-funding from EDCTP2 and the Swedish International Development Agency. Designed as a dispersible tablet with a sweet cherry flavor, it aims to facilitate administration and ensure precise dosing for the smallest infants.
Health experts assert that the WHO prequalification affirms that Coartem® Baby meets international standards of quality, safety, and efficacy. This certification paves the way for its inclusion in global procurement agencies' malaria treatment programs. For many years, healthcare providers have faced challenges in treating malaria in newborns due to the lack of appropriately tailored medications, often resorting to using formulations meant for older children, which risked incorrect dosing and potential side effects.
The PAMAfrica consortium conducted the CALINA trial from 2020 to 2024 across several African countries, including Burkina Faso, the Democratic Republic of Congo, Kenya, Mali, Nigeria, and Zambia. The study found that the medicine achieved effective drug levels comparable to those in older children while maintaining a robust safety profile. These findings led to its market authorization by Swissmedic in July 2025.
Global Health EDCTP3, a Europe-Africa partnership supported by the European Union and more than 40 countries, continues to drive research into infectious diseases affecting sub-Saharan Africa, focusing on transforming scientific innovation into practical health solutions. The introduction of Coartem® Baby is anticipated to enhance survival rates and treatment outcomes among one of the most vulnerable patient groups in malaria-endemic regions.