In what experts have described as a groundbreaking step for malaria treatment, a new drug formulation specifically developed for babies weighing less than 5 kilograms is set to be introduced across Africa, offering a lifeline to one of the most vulnerable pediatric populations.
The new treatment—Coartem® Baby, a pediatric formulation of the widely used artemether-lumefantrine combination—was developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV).
It targets neonates and low-weight infants previously excluded from standard dosing guidelines due to the risk of under- or overdosing from existing malaria therapies.
Filling a Deadly Treatment Gap
Until now, babies under 5kg had to rely on weight-adjusted dosages of drugs intended for heavier children—a method often imprecise and risky given their immature metabolism and organ function.
Malaria remains a leading cause of death in Africa, with children under five accounting for nearly 75% of malaria-related deaths. In 2023 alone, sub-Saharan Africa recorded around 90% of the global malaria death toll.
Speaking on the urgency of the situation, Dr. Shreeram Aradhye, Chief Medical Officer at Novartis, stated:
“We are pleased with the positive outcomes from our CALINA study and to be one step closer to bringing an effective malaria treatment option to the most vulnerable patients—newborn babies who, until now, had no approved treatment.”
Proven Safety and Efficacy
The formulation underwent CALINA, a rigorous Phase II/III trial conducted across eight African countries, including Kenya, Uganda, and Nigeria.
The study confirmed Coartem Baby’s strong efficacy, appropriate pharmacokinetics, and safety profile, making it the first dedicated malaria treatment approved for this fragile weight group.
Dr. Wiweka Kaszubska, Executive VP at MMV, emphasized the importance of the development:
“Infants below 5 kg make up a critical, neglected group. Developing antimalarials specifically suited to their needs is essential to malaria control efforts and to achieving equitable access to life-saving treatments.”
Non-Profit Commitment and Public Rollout
The formulation has been submitted for regulatory review and is expected to receive approval later this year. Once approved, Novartis has pledged to distribute the drug on a non-profit basis, continuing its tradition with pediatric Coartem, which has already seen over 300 million dispersible treatments delivered globally.
“This commitment aligns with our broader goal to improve health equity,” added Aradhye. “With support from local health ministries, this rollout will be swift and far-reaching.”
Public health advocates hail the upcoming launch of Coartem Baby as a crucial milestone in the ongoing fight against malaria.
If approved, the treatment is expected to significantly reduce infant mortality rates and improve clinical outcomes for thousands of newborns across malaria-endemic regions.
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