Swissmedic Approves First Malaria Drug for Newborns

Novartis has received approval from Swissmedic for Coartem Baby, a dissolvable malaria drug specifically designed for newborns and infants under 4.5 kilograms, addressing a longstanding treatment gap. The medication is easy to administer and aims to reduce overdose risks associated with using drugs intended for older children. Eight African countries that participated in the assessment process are expected to quickly approve and deploy the drug, which will be distributed largely on a not-for-profit basis. Malaria continues to kill over 260,000 children under five annually in Africa, with infants previously at heightened risk due to the lack of suitable treatment options. Coartem Baby was developed in partnership with the Medicines for Malaria Venture, and its approval is based on robust clinical data from the CALINA study. Public health experts describe the approval as a major step forward for pediatric malaria care in endemic regions.