US EditionNovartis gets approval for first malaria drug for babies and children
- On July 8, 2025, Swissmedic approved Coartem Baby, the first malaria treatment for infants under 5 kg, marking a significant global health milestone.
- Until now, no approved malaria drugs existed for infants under 4.5 kg, risking overdose from off-label use of older formulations, leaving a critical treatment gap for the most vulnerable.
- Swissmedic approved Coartem Baby on July 8, 2025, based on Phase II/III CALINA trial data supporting its safe, optimized dosing for infants under 5 kg, marking a milestone in malaria treatment.
- Novartis plans to deploy the drug in eight African countries within weeks on a largely not-for-profit basis, addressing a critical malaria treatment gap for infants.
- Swissmedic approved Coartem Baby on July 8, 2025, addressing a critical treatment gap for infants under 4.5kg; this milestone aims to reduce child mortality in malaria-endemic regions.
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First malaria treatment for babies is approved
The NewsMedicine to treat babies and young infants suffering from malaria has been approved for the first time and is expected to be rolled out in Africa within weeks.Malaria treatment for infants weighing less than 4.5 kilograms has been unavailable until now, due to the risk of overdose. Coartem Baby, the new medicine, was produced by pharmaceutical giant Novartis and has been approved by Swissmedic, Switzerland’s regulator for therapeutic pro…
·New York, United States
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