In a historic breakthrough, the World Health Organization has granted prequalification approval to the first-ever malaria treatment specifically designed for newborns and infants. The drug, artemether-lumefantrine, marks a critical advancement in protecting the youngest and most vulnerable from one of the world’s deadliest infectious diseases.
Malaria continues to be a major global health challenge, particularly affecting children under five. Until now, infants were treated using malaria drugs formulated for older children, increasing the risk of incorrect dosing, side effects, and toxicity. The newly approved infant-specific formulation addresses this gap by offering safe, precise, and age-appropriate treatment. "The prequalification designation indicates that the medicine meets international standards of quality, safety and efficacy," the WHO said in a statement.
According to WHO, the prequalification status confirms that the medicine meets international standards of quality, safety, and efficacy, paving the way for wider global distribution, especially in low-resource, malaria-endemic regions.
Up to now, infants have been treated with formulations intended for older children - carrying a greater risk of dosage errors, side effects and toxicity. "For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities," said WHO chief Tedros Adhanom Ghebreyesus. "But today, the story is changing. New vaccines, diagnostic tests, next-generation mosquito nets and effective medicines, including those adapted for the youngest, are helping to turn the tide."
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Infants are especially susceptible to severe malaria, particularly infections caused by Plasmodium falciparum, the most dangerous parasite strain. Without timely and accurate treatment, the disease can quickly lead to complications such as severe anemia, organ failure, and death. This new formulation of artemether-lumefantrine is designed to:
The urgency of this innovation is underscored by alarming global statistics. In 2024 alone, there were an estimated 282 million malaria cases and 610,000 deaths across 80 countries, according to the WHO. A significant proportion of these deaths occur among young children, making targeted treatments like this essential.
The UN health agency says progress against malaria is being hampered by drug resistance, insecticide resistance, diagnostic failure, and sharp reductions in foreign aid spending. The WHO said its prequalification would enable public sector procurement and help close a long-standing treatment gap for around 30 million babies born each year in malaria-endemic areas of Africa.
Malaria continues to be a major global health challenge, particularly affecting children under five
The approval of this infant malaria treatment is part of a broader global strategy to combat the disease. Experts believe this development strengthens the fight against malaria and brings the world closer to long-term elimination goals. Alongside innovations such as:
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