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Swissmedic Approves Coartem Baby as First Malaria Treatment for Newborns

SWITZERLAND, JUL 8 – Novartis will roll out the first malaria treatment for newborns in African regions with high malaria rates, addressing a gap affecting children under five responsible for 75% of deaths, WHO data show.

  • 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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Center

The Swiss Medicines Agency Swissmedic has approved a paediatric medicine for malaria. According to the authority, the medicine Riamet Baby from the pharmaceutical manufacturer Novartis was developed specifically for infants weighing between two and five kilograms.

·Germany
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+6 Reposted by 6 other sources
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First malaria drug for newborns and young infants expected to be approved in Africa within weeks

The approval of the first malaria treatment for newborns and young infants could lead to imminent widespread use in Africa, drugmaker Novartis said Tuesday.

·Atlanta, United States
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Euronews broke the news in France on Tuesday, July 8, 2025.
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