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For the first time ever, treatment for malaria specifically designed for newborns and small infants has received regulatory approval, which is exciting for millions across Africa, where malaria remains a serious public health threat.
Malaria remains a huge public health challenge, particularly throughout Sub‑Saharan Africa.
The World Health Organization reported 597,000 deaths in 2023 from malaria, over 95% in Africa, with three‑quarters involving children less than five years of age. Yet until now, there has not been a safe approved treatment for infants less than 4.5.
Caregivers have previously had to resort to breaking adult tablets or using untested dosing methods, risking overdose or under‑treatment.
As of early this month, Swissmedic, the Swiss regulatory authority, approved Coartem Baby (Riamet Baby) which has been developed in conjunction with Novartis and the Medicines for Malaria Venture. The formulation comes as a cherry flavored, dissolvable formulation, which can dissolve with breast milk, and is specifically developed for infants who weigh 2–5 kg.
Health workers can now dose accordingly, with much lower risk of toxicity in very young infants who are the most vulnerable age category.
Swiss approval is the first step. The eight African countries; Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda were involved in the clinical evaluations and will hopefully issue national approval within 90 days.
Ghana has already approved Coartem Baby, and a more general rollout across endemic territories should be forthcoming.
