WHO Clears World's First Malaria Treatment Designed Specifically for Newborns and Young Infants

For the first time in history, newborns and the smallest infants battling malaria have a treatment designed with them in mind. The World Health Organization announced on World Malaria Day, April 25, that it has granted prequalification to artemether-lumefantrine — sold under the name Coartem Baby — marking a historic milestone in the fight against one of the world's most deadly diseases.

The newly approved treatment is the first antimalarial formulated specifically for newborns and young infants weighing between two and five kilograms. Until now, infants had been treated with formulations intended for older children, carrying a greater risk of dosage errors, side effects, and toxicity.

Until now, there had been no approved malaria treatment for infants weighing less than 4.5 kilograms — roughly 10 pounds — leaving doctors with few safe options for their youngest patients. WHO prequalification will enable public sector procurement, contributing to closing a long-standing treatment gap for some 30 million babies born each year in malaria-endemic areas.

Malaria remains a major global health burden, with WHO data showing 282 million cases and 610,000 deaths in 2024. Almost all deaths occurred in Africa, where children under five accounted for around three in four malaria deaths.

Coartem Baby was developed by Novartis and the Medicines for Malaria Venture, with co-funding from the European and Developing Countries Clinical Trials Partnership and the Swedish International Development Agency through the PAMAfrica consortium. Between 2020 and 2024, the PAMAfrica consortium conducted the CALINA trial across Burkina Faso, the Democratic Republic of Congo, Kenya, Mali, Nigeria, and Zambia to evaluate the treatment's effectiveness and safety. The results showed that Coartem Baby achieved therapeutic drug levels in the bloodstream comparable to those observed in older children, supporting effective parasite clearance.

Novartis plans to introduce the treatment — dissolvable even in breast milk and made in a sweet cherry flavor — on a largely not-for-profit basis to increase access in malaria-endemic countries. The eight African nations that took part in the trials are expected to be among the first to receive it, with rollout anticipated within weeks.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus marked the occasion with a call to action. "For centuries, malaria has stolen children from their parents, and health, wealth and hope from communities," he said. "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."

Martin Fitchet, CEO of the Medicines for Malaria Venture, underscored the significance of cross-sector collaboration. "For too long, newborns and young infants with malaria have fallen through the cracks because existing treatments were not designed with them in mind. This achievement shows what is possible when partners come together to translate scientific innovation into real-world impact."

The approval coincides with the launch of the 2026 World Malaria Day campaign, "Driven to End Malaria: Now We Can. Now We Must" — a theme that reflects cautious optimism tempered by an urgent reminder that continued political will and financial investment remain essential to realizing a malaria-free future.