The World Health Organization (WHO) has announced the prequalification of a malaria treatment designed specifically for newborns and infants, marking a major milestone in the fight against the disease.
The newly approved drug, Artemether-lumefantrine, is the first antimalarial formulation tailored for the youngest and most vulnerable patients affected by the mosquito-borne illness.
According to the WHO, the prequalification status confirms that the medicine meets international standards of quality, safety, and effectiveness. Until now, infants were typically treated with medications formulated for older children, a practice that increased the risk of dosage errors, side effects, and toxicity.
WHO Director-General, Dr. Tedros Adhanom Ghebreyesus, described the development as a turning point in malaria control efforts, noting that advances in vaccines, diagnostics, mosquito nets, and medicines are helping to shift the tide against the disease.
He emphasized that while ending malaria is now within reach, it will require sustained political and financial commitment.
Recent WHO data shows that in 2024 alone, there were an estimated 282 million malaria cases and 610,000 deaths across 80 countries, with Africa bearing about 95 percent of the burden. Children under five account for roughly three-quarters of malaria-related deaths.
The organization also highlighted challenges such as drug and insecticide resistance, diagnostic gaps, and declining international funding, which continue to slow progress.
WHO said the approval will support global procurement efforts and help address treatment gaps for an estimated 30 million babies born annually in malaria-endemic regions, particularly in Africa.
The prequalification programme ensures that medicines and health products meet global standards, especially in countries with limited regulatory capacity.


