First malaria medicine for infants under 4.5kg receives approval
Ella Day | July 9, 2025 | News story | Medical Communications, Research and Development |Â Â Coartem Baby, Infections and infestations, Medicines for Malaria Venture, Novartis, Paediatrics, Swissmedic, malariaÂ
Coartem (artemether-lumefantrine) Baby, or Riamet, has been approved by Swissmedic as the first malaria medicine for newborns and young infants. It was developed through a collaboration between Medicines for Malaria Venture (MMV) and Novartis to treat potentially deadly mosquito-borne diseases in infants weighing less than 4.5kg, who had no treatment options until now.
Rapid approvals in eight African countries are expected under the Swissmedic’s marketing authorisation for global health products procedure.
The patient group has been treated with formulations intended for use in older children, posing a risk of overdose and toxicity. With children under five years of age accounting for about three in four malaria deaths in the regions where malaria is a risk, providing effective treatments for all infants is an utmost priority.
The approval is based on positive results from the CALINA clinical study, which investigated a new ratio and dose of Coartem to account for metabolic differences in babies under 5kg.
The treatment is dissolvable, including in breast milk, and has a sweet cherry flavor, making it easier to administer to babies. Administration will take place on a largely not-for-profit basis to increase access in areas where malaria is endemic.
Malaria is a life-threatening disease caused by a parasite that is spread to humans by certain types of mosquitoes. Approximately 30 million babies are born in area where malaria is a risk in Africa every year.
Ella Day
9/7/25
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