The World Health Organization on Friday granted prequalification approval to the first malaria treatment specifically designed for newborns and infants, marking a significant step in tackling the disease among the most vulnerable.
The treatment, Artemether-lumefantrine, is the first formulation tailored for infants. Until now, babies have been treated using medicines intended for older children, raising risks of dosage errors, side effects, and toxicity.
The WHO said the prequalification confirms the drug meets international standards of quality, safety, and efficacy, allowing it to be procured by public health systems globally.
WHO Director-General Tedros Adhanom Ghebreyesus said the development could help change the trajectory of the disease, which has long affected children disproportionately.
According to the WHO, there were an estimated 282 million malaria cases and 610,000 deaths across 80 countries in 2024. Africa accounted for 95 percent of cases and deaths, with children under five making up three-quarters of fatalities.
The agency said the approval could help address a treatment gap affecting around 30 million babies born each year in malaria-endemic regions of Africa.
However, it warned that progress against malaria continues to face challenges, including drug resistance, insecticide resistance, diagnostic failures, and declining foreign aid.
The WHO added that its prequalification programme plays a key role in ensuring medicines, vaccines, and diagnostics meet global standards, especially in countries where regulatory systems remain limited.