US EditionSwissmedic 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.
118 Articles
118 Articles
First-Ever Treatment for Malaria in Infants and Children Wins Regulatory Approval
Swiss medical authorities have approved the first drug suitable to treat malaria in babies and very young children. Eight African countries that participated in clinical trials are now poised to approve the malaria treatment, which is dissolvable and can be mixed with breast milk, making it easy to administer. Malaria kills about 600,000 people worldwide each year, a majority of them children under the age of 5.
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.
NBC Dallas-Fort Worth
First malaria treatment for babies approved for use
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