The World Health Organization has prequalified the first antimalarial specifically designed for newborns and young infants, opening the door to wider public‑sector use in countries with high malaria burdens. Malaria remains a leading killer of children: in some areas of Africa up to 18% of infants under six months are infected, and in 2024 there were about 610,000 malaria deaths worldwide, roughly three‑quarters among children under five in Africa.
Until now, infants with malaria were treated with formulations meant for older children, raising the risk of dosing mistakes, side effects and toxicity. The newly prequalified medicine, Coartem Baby, is approved for babies weighing from 2 kg (4.4 lb). It is a cherry‑flavoured tablet that dissolves in liquids, including breast milk, to make administration easier for caregivers. WHO prequalification indicates the product meets international standards for quality, safety and efficacy and will enable procurement by many high‑burden countries, particularly across sub‑Saharan Africa.
Coartem Baby combines the antimalarials artemether and lumefantrine and was developed by Novartis in partnership with the Medicines for Malaria Venture (MMV). Its approval follows research that overturned the long‑held assumption that infants are reliably protected from malaria by maternal antibodies passed during pregnancy and breastfeeding.
WHO director‑general Tedros Adhanom Ghebreyesus said the decision represents a significant shift in efforts to protect the youngest children from a disease that has devastated families and communities. MMV’s chief executive, Martin Fitchet, described the milestone as an important advancement for public health, noting that newborns and young infants previously lacked treatments tailored to their needs. Public‑health leaders point to this approval alongside new vaccines, improved diagnostics and next‑generation mosquito nets as signs of progress against malaria.
Coartem Baby has already been introduced in Ghana. One infant who received the treatment at 12 weeks after a fever and high parasite levels has since recovered and is thriving; clinicians there say the formulation gives them greater confidence when treating sick newborns who previously had few suitable options.
Novartis has said it will supply Coartem Baby largely on a not‑for‑profit basis in malaria‑endemic regions. The Medicines for Malaria Venture receives support from multiple donors, including the Bill & Melinda Gates Foundation.