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Novartis 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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Euronews broke the news in France on Tuesday, July 8, 2025.
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