A newly approved malaria treatment designed specifically for newborns and very small infants is being hailed by global health experts as a major breakthrough in the fight against one of the world’s deadliest diseases. The drug, marketed as Coartem Baby — and known in some countries as Riamet Baby — has been developed by Swiss pharmaceutical company Novartis in collaboration with the Medicines for Malaria Venture (MMV), with backing from the World Health Organization (WHO).
Unlike previous malaria treatments, the formulation is tailored for babies weighing between 2 and 5 kilograms — a group that has long faced limited treatment options. Health officials say the approval addresses a critical gap in pediatric malaria care, particularly in sub-Saharan Africa, where malaria remains a leading cause of child mortality.
why this drug matters
According to WHO data, children under the age of five account for the vast majority of malaria deaths worldwide, with the African region bearing the heaviest burden. In many malaria-endemic countries, the disease remains one of the top causes of hospital admissions and childhood fatalities. More regional health updates can be found in our medicine coverage.
Until now, clinicians treating infants under 5 kilograms often had to rely on modified doses of medicines designed for older children or adults. These formulations were typically bitter, difficult to administer, and carried risks of underdosing or overdosing. Inaccurate dosing can increase the chances of treatment failure or contribute to drug resistance — a growing concern in malaria control efforts.
Coartem Baby is a fixed-dose combination of artemether and lumefantrine, two well-established antimalarial compounds that have been used for more than two decades as frontline therapy. The new formulation is sweet, dispersible, and designed to dissolve easily in breast milk or water, making it significantly easier for caregivers to administer safely.
how the treatment works
The medicine combines two complementary mechanisms. Artemether acts rapidly, reducing the number of malaria parasites in the bloodstream within hours. Lumefantrine works more slowly but remains active in the body longer, clearing residual parasites and reducing the risk of recurrence.
This dual-action approach has been the global standard for treating uncomplicated malaria, but previous versions were not optimized for neonates and very small infants. By tailoring the dosage precisely for babies between 2 and 5 kilograms, the new treatment provides both safety and efficacy in a population that is particularly vulnerable to complications.
Health experts say early and accurate treatment is essential in infants, whose immune systems are not yet fully developed. Delays or ineffective therapy can lead to severe malaria, anemia, organ failure, or death.
impact across africa
Countries with high malaria transmission rates are expected to benefit most from the rollout. Uganda, which has one of the highest malaria burdens globally, has already begun integrating the treatment into national protocols. Nigeria, Kenya, and Tanzania are among several African nations included in a coordinated approval framework designed to accelerate distribution.
The approval process was supported through a special global health pathway that allowed regulatory authorities in multiple African countries to review the drug simultaneously. This approach is intended to reduce delays that often slow access to lifesaving medications in lower-income regions.
Broader coverage on disease prevention and emerging treatments is available in our health & science section, including ongoing reporting on climate-linked disease patterns in our climate change category.
access and affordability
Novartis and its partners have stated that Coartem Baby will be introduced largely on a not-for-profit basis in malaria-endemic countries. Public health advocates say affordability will be crucial to ensuring that the treatment reaches rural and underserved communities, where malaria transmission rates are often highest.
Global health organizations continue to emphasize that medication alone is not enough to eliminate malaria. Prevention strategies — including insecticide-treated bed nets, indoor residual spraying, rapid diagnostic testing, and vaccine deployment — remain central to reducing transmission and mortality.
a broader fight against malaria
The development of a newborn-specific treatment reflects a wider shift toward precision in global health interventions. Rather than adapting adult therapies for children, researchers are increasingly designing medicines that reflect the unique physiology and dosage needs of infants.
While challenges remain — including funding gaps, evolving parasite resistance, and healthcare access barriers — experts say the availability of a properly dosed treatment for the smallest patients marks a significant milestone. If implemented effectively, the drug could prevent thousands of deaths annually in regions hardest hit by malaria.
For millions of families across Africa and other malaria-endemic regions, the approval offers cautious optimism that fewer children will be lost to a disease that has claimed young lives for generations.
