A landmark milestone in global health has been reached as the antimalarial drug Coartem Baby has received approval from the Swiss regulator Swissmedic. It is the first treatment specifically designed for newborns and very young infants suffering from malaria.
Bridging a critical treatment gap
For decades, infants weighing less than 4.5 kilograms have been treated with antimalarial medicines originally developed and approved only for older children and adults. This created risks of overdose or toxicity because of infants’ immature organ systems. The new formulation of artemether lumefantrine is tailored for the smallest patients, weighing between two and five kilograms, and comes with infant friendly features such as a dispersible form and a flavour that makes administration easier.
Clinical development and approval pathway
The medicine was developed through a collaboration between Novartis and the non profit organisation Medicines for Malaria Venture and was reviewed under Swissmedic’s Marketing Authorisation for Global Health Products scheme. The approval was based on phase two and three clinical trial data in infants from African countries involved in the research. Following Swissmedic’s decision, eight African nations that participated in the assessment are expected to fast track their national approvals.
Why this is important
Malaria remains one of the world’s deadliest diseases, particularly for children under five in sub Saharan Africa. In 2023, there were an estimated 263 million cases and nearly 600,000 deaths, the vast majority among young children. Infants are especially vulnerable yet have until now lacked a treatment specifically approved for their age and weight group. The new approval represents an important step towards reducing infant mortality from malaria. Clinical experts have described the development as a major advancement for one of the most neglected groups in malaria care.
Features of the infant specific formulation
Coartem Baby uses the same active ingredients, artemether and lumefantrine, as earlier Coartem formulations but at an optimised dose and form for infants. Key features include a lower dose strength validated for infants weighing two to five kilograms, a dispersible tablet that can be dissolved in breast milk or water for easy administration, and a palatable flavour to encourage adherence. The product will be distributed largely on a not for profit basis in malaria endemic countries, reflecting a focus on access and equity.
Implementation and access challenges
Despite the approval, the full benefit will depend on rapid rollout and uptake in endemic countries. Key considerations include national regulatory approvals, as countries still need to authorise Coartem Baby for local use, and robust supply chains to ensure the medicine reaches rural and low resource settings. Healthcare workers will also need training to diagnose malaria in infants, who often show atypical symptoms, and to administer the correct dose. Monitoring for drug resistance and ensuring sustainable funding are further priorities for long term success.
Broader implications for malaria elimination
This approval marks a major advance in paediatric malaria care and supports the global targets set by the World Health Organization to reduce malaria cases and deaths by 2030. Having a treatment specifically approved for infants closes a critical gap in the available toolkit, complementing preventive measures such as bed nets, vector control and vaccination.
While malaria vaccines are now available for children from about five months of age, very young infants, including those under six months, previously had no targeted treatment. The introduction of Coartem Baby extends protection to this youngest and most vulnerable group, offering hope for further reductions in child mortality in the years ahead.
The Approval
The approval of Coartem Baby for newborns and young infants is a landmark moment in the global fight against malaria. By combining a child specific formulation, global access commitments and rapid regulatory pathways, this breakthrough has the potential to save thousands of young lives every year. The next steps will be crucial: ensuring that the treatment reaches the infants who need it most, integrating it into national malaria programmes and scaling up alongside other preventive tools to move closer to the goal of malaria elimination.
