Ghanaian newborns get Coartem Baby treatment as Ghana becomes the first country in the world to roll out a malaria formulation specially designed for babies under 5 kg. The new drug, branded Coartem <5 kg Baby, adjusts the artemether-lumefantrine ratio to suit infants whose metabolic systems are still immature, aiming to reduce dosing risks.
Approval for the therapy was granted in Ghana in February 2025 and subsequently by Swissmedic in July, enabling Ghana to lead with early adoption. Until now, infants under 4.5–5 kg had received formulations meant for older children—a practice that increased the danger of overdosing, underdosing, or treatment failure.
Coartem Baby was developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV). The formulation was validated through the CALINA trial, conducted across eight African countries under the PAMAfrica consortium. The trial confirmed safety and efficacy in newborns, whose unique physiology demands precise pharmacological adjustments.
Infants in malaria-endemic regions are especially vulnerable because partial immunity, placental malaria, or mosquito exposure may already affect them at birth. The incidence of malaria in infants under six months has been observed in some West African surveys at rates ranging from 3.4% to 18.4%.
Novartis has pledged to introduce this new treatment largely on a not-for-profit basis, recognizing the urgent need to protect the most vulnerable. MMV’s CEO hailed Ghana’s leadership in approving the drug as a landmark step in malaria control.
As the rollout proceeds, key challenges remain: ensuring stable supply, managing distribution to remote areas, training frontline health workers, and maintaining community trust. If executed well, the initiative may significantly lower newborn deaths from malaria and serve as a model across Africa.
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