The first malaria treatment specifically formulated for babies and very young children has been approved and will be introduced in African countries within weeks.
The drug, named Coartem Baby (also marketed as Riamet Baby), is designed for infants under 4.5kg. Until now, no approved malaria drug existed for this age and weight group. Babies were previously treated with scaled-down doses meant for older children, risking overdose due to underdeveloped liver function.
In 2023, malaria caused approximately 597,000 deaths. Three-quarters of them are children under five, mostly in Africa.
Developed by Novartis in partnership with the Medicines for Malaria Venture (MMV), the drug was tested in collaboration with eight African countries and has been approved by Swiss health authorities. Novartis will distribute the medicine on a largely not-for-profit basis.
The treatment fills a longstanding gap in care. Health experts say its availability can reduce child mortality in malaria-endemic regions.
Novartis CEO Vas Narasimhan said the approval ensures that “even the smallest and most vulnerable” can now access targeted malaria care.
MMV CEO Martin Fitchet called it “a necessary medicine with an optimized dose” for newborns and infants.
Dr. Marvelle Brown of the University of Hertfordshire said the move addresses a key inequality in malaria care and will have significant public health impact.
The rollout is expected to begin in high-burden regions within weeks.