First malaria treatment for babies and young infants receives approval

08 July 2025

Swissmedic has granted authorisation of Coartem® (artemether-lumefantrine) Baby as the first malaria treatment specifically for young infants weighing less than 5 kg. This milestone follows positive results from the CALINA study conducted by the EDCTP2-funded PAMAfrica consortium. Developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV) and various European and African institutions, this formulation offers new hope in the fight against malaria.

Eight African countries participated in the CALINA study to evaluate Coartem® (artemether-lumefantrine) Baby and are now expected to issue rapid approvals under Swissmedic’s  Marketing Authorization for Global Health Products procedure. Importantly, Novartis intends to introduce this infant-friendly treatment on a largely not-for-profit basis to make it accessible and available in malaria-endemic areas.

“We congratulate Novartis and the PAMAfrica project investigators for their collaboration in developing a much-needed, effective treatment for young children suffering from malaria shortly after birth. The approval of Coartem® Baby addresses a critical gap in suitable antimalarial treatments for young infants. EDCTP is honoured to be part of this remarkable achievement.”

Dr Montserrat Blázquez-Domingo, Senior Project Officer, EDCTP Association

Each year, three-quarters of malaria deaths occur in children under five years of age, but to date, there has been no tailored antimalarial treatment for very small young children weighing less than 5 kg. Instead, they were administered a fraction of the standard dose, raising concerns about excessively high levels of the active antimalarial compounds, artemether and lumefantrine, due to the immaturity of their metabolism.

With support from the EDCTP2 programme, including funding from the Swedish International Development Cooperation Agency (Sida), the PAMAfrica Consortium tested a dispersible formulation of artemether-lumefantrine designed for babies and infants weighing less than 5 kg in the CALINA trial. The CALINA trial, conducted by researchers in Burkina Faso, the Democratic Republic of the Congo, Kenya, Mali, Nigeria and Zambia, demonstrated that the new formulation, Coartem® Baby, achieved bloodstream levels of the drugs proven to effectively eliminate malaria parasites, similar to those shown in older children, and provided key additional safety data. The CALINA trial results contributed to the market authorisation by Swissmedic for this formulation, suggesting that the new treatment is both efficacious and safe for use in young children.

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