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For the first time, a malaria treatment specifically formulated for newborns has received approval from Swissmedic, Switzerland’s drug regulatory authority. The new medication, named Coartem Baby, is designed for infants weighing less than five kilograms, addressing a significant gap in malaria care for the most vulnerable population.
Developed by pharmaceutical company Novartis, Coartem Baby aims to protect infants under two months old, who are at a heightened risk for malaria. Historically, these newborns have been treated with adjusted doses of medications intended for older children, which increased the likelihood of side effects due to differences in drug metabolism in young infants.
The World Health Organization reports that malaria remains a major health threat, particularly in Africa, where it claimed approximately 597,000 lives in 2023, with a majority of victims being children under five. The new treatment is especially critical in regions where malaria is endemic, as it fills a void in care for newborns who are typically not eligible for malaria vaccines until they reach around five months of age.
Coartem Baby is a re-engineered version of Novartis’ pediatric antimalarial drug, featuring a modified dose and ingredient ratio to reduce side effects. The medication is also designed to be more palatable for infants, featuring a cherry flavor that can be easily mixed with breast milk.
Late-stage clinical trials have confirmed the safety and efficacy of Coartem Baby for infants under five kilograms. The approval of this drug is set to significantly impact malaria treatment in African countries, with Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda expected to introduce the medicine quickly. These nations are collaborating with Swissmedic to expedite access to this lifesaving treatment.
Novartis plans to distribute Coartem Baby in these countries by autumn 2023, on a not-for-profit basis. The introduction of this specialized medication is seen as a monumental step in the global fight against malaria, bringing hope to millions of families in Africa and marking a significant advancement in healthcare for newborns.
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