WHO Approves First Malaria Treatment for Newborns and Infants

The World Health Organization has approved the first malaria treatment for newborns, artemether-lumefantrine, to improve safe care for infants and reduce treatment gaps in high-risk countries, especially in Africa where most malaria deaths occur.

The World Health Organization has announced a major milestone in global health efforts by granting prequalification approval to a malaria treatment designed specifically for newborns and infants for the first time. The drug, artemether-lumefantrine, is the first antimalarial medicine created with the youngest and most vulnerable patients in mind, marking a significant step forward in addressing a long-standing gap in malaria care.
According to the WHO, the prequalification status means the medicine has met strict international standards for quality, safety, and effectiveness. This approval is particularly important because it allows governments, humanitarian agencies, and global procurement bodies to confidently purchase and distribute the drug for use in public health systems.
Until now, infants suffering from malaria have typically been treated using formulations originally designed for older children. This practice has created serious challenges, including a higher risk of incorrect dosing due to weight and age differences, as well as increased chances of side effects and drug toxicity. Health experts have long warned that this gap in appropriate treatment options leaves newborns especially vulnerable in malaria-endemic regions.
WHO Director-General Tedros Adhanom Ghebreyesus described the development as a turning point in the global fight against malaria. He noted that for centuries, the disease has caused immense suffering, taking the lives of children and placing heavy social and economic burdens on families and communities. However, he emphasized that the situation is now beginning to change due to advances in medical science, including new vaccines, improved diagnostic tools, next-generation mosquito nets, and more targeted medicines designed for different age groups.
He further stated that eliminating malaria is no longer just an aspiration but a realistic goal, provided there is consistent political commitment and sufficient financial investment from governments and international partners.
Malaria continues to be one of the world’s deadliest infectious diseases. In 2024 alone, an estimated 282 million cases and 610,000 deaths were recorded across 80 countries. The burden is overwhelmingly concentrated in Africa, which accounts for about 95 percent of global cases and deaths. Within this group, children under the age of five are the most affected, representing roughly three-quarters of all malaria-related deaths, highlighting the urgent need for child-specific treatment solutions.
Despite progress in prevention and treatment over the years, the WHO warned that global efforts are being slowed by several persistent challenges. These include growing resistance to antimalarial drugs, resistance to insecticides used in mosquito control, weaknesses in diagnostic systems, and a significant reduction in international funding for malaria programmes. Together, these factors threaten to stall or reverse recent gains in disease control.
The WHO explained that its prequalification programme plays a crucial role in strengthening global health systems by ensuring that medicines, vaccines, diagnostic tools, and other medical products used in international procurement meet established global standards. It also highlighted that around 70 percent of countries lack strong regulatory systems capable of fully overseeing the safety and quality of health products, making WHO approval especially important for ensuring access to reliable treatments.
The introduction of this infant-specific malaria treatment is expected to help close a long-standing treatment gap affecting an estimated 30 million babies born each year in malaria-endemic regions, particularly in Africa, where the disease remains a major public health threat.