EuroWire, GENEVA: The World Health Organization has prequalified the first malaria treatment developed specifically for newborns and young infants, giving global health agencies a new option for a group long treated with medicines designed for older children. The medicine, artemether-lumefantrine, is indicated for babies weighing 2 to 5 kilograms and is marketed by Novartis as Coartem Baby, or Riamet Baby in some countries. WHO said the designation confirms that the product meets international standards for quality, safety and efficacy.
The decision marks a new stage for a treatment gap that has persisted in countries where malaria remains widespread. Until now, infants in this weight range who contracted malaria were generally treated with formulations intended for older children, a practice that health authorities say can raise the risk of dosing errors, side effects and toxicity. WHO said the new formulation is aimed at one of the most underserved patient groups, with about 30 million babies born each year in malaria-endemic parts of Africa.
The treatment had already cleared a major regulatory step before the WHO action. Swissmedic granted marketing authorization for the product on July 8, 2025, under its Marketing Authorisation for Global Health Products procedure. The Swiss regulator said the assessment involved authorities from Burkina Faso, Cote d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Uganda and Tanzania, with participation from the WHO Global Malaria Programme. That authorization established the medicine as a dedicated malaria treatment for infants weighing between 2 and 5 kilograms.
WHO prequalification opens wider access
WHO prequalification is a critical benchmark for public health purchasing because it is used by United Nations agencies and other institutional buyers when evaluating products for donor-funded and government-backed supply programs. Novartis said the step should support broader access through public sector channels in malaria-endemic countries. The company also said it is making the treatment available on a largely not-for-profit basis in those markets and that the product has already been introduced in Ghana.
The medicine was developed by Novartis in collaboration with Medicines for Malaria Venture, reflecting a broader push to adapt malaria tools for patient groups that have often been excluded from standard product development. In its statement, WHO described the therapy as the first antimalarial formulation designed specifically for the youngest malaria patients. Novartis said there had previously been no approved malaria treatment specifically developed for infants weighing less than 4.5 kilograms, leaving clinicians to rely on older-child formulations for the smallest patients.
Malaria Burden Keeps Pressure On Health Systems
The WHO announcement came ahead of World Malaria Day, as the agency highlighted the continued strain the disease places on health systems. According to the latest WHO figures cited in the release, the world recorded an estimated 282 million malaria cases and 610,000 deaths in 2024, with almost all deaths occurring in Africa. The agency linked the infant treatment milestone to wider efforts to improve malaria control through better medicines, stronger diagnostics and more reliable access to quality-assured products.
WHO also said this month it had prequalified three new rapid diagnostic tests designed to address false negative results linked to pf-hrp2 gene deletions in some malaria parasites, underscoring the broader push to close gaps in diagnosis and treatment. For the infant therapy itself, the latest WHO action gives the product both an international procurement benchmark and a clearer route into public health programs after its earlier Swissmedic approval. That combination makes it the first malaria treatment tailored to newborns and young infants in this weight group.