A groundbreaking step in global health, the World Health Organization (WHO) has approved the first-ever malaria treatment specifically designed for newborns, offering fresh hope in the fight against one of the world’s deadliest diseases.
The newly approved drug, Coartem Baby, is expected to transform care for infants under six months old—an age group historically left without safe, targeted treatment options.
A long-overdue breakthrough
Malaria continues to exact a devastating toll worldwide. In 2024 alone, an estimated 610,000 people died from the disease, with nearly 75% of fatalities occurring among children under five in Africa. Until now, infants were often treated using medications designed for older children, raising serious risks of incorrect dosing, toxicity, and harmful side effects.
Health experts say the approval of Coartem Baby fills a critical gap.
“For centuries, malaria has stolen children from their parents and hope from communities,” said Tedros Adhanom Ghebreyesus. “But today, the story is changing.”
Designed specifically for infants
Developed by Novartis in partnership with Medicines for Malaria Venture (MMV), the treatment combines two proven antimalarial compounds—artemether and lumefantrine—in a formulation tailored for very small infants.
The drug can be administered to babies weighing as little as 2 kilograms and comes in sweet cherry-flavored tablets that dissolve easily in liquids, including breast milk—making it easier for caregivers to administer safely.
WHO prequalification confirms the drug meets global standards for quality, safety, and effectiveness, paving the way for large-scale procurement in malaria-endemic regions, particularly across sub-Saharan Africa.
Changing old assumptions
For decades, medical thinking suggested newborns were protected against malaria due to maternal immunity passed during pregnancy and breastfeeding. However, emerging research has overturned that belief, revealing that infants remain vulnerable—especially in high-transmission regions where up to 18% of babies under six months may be infected.
“This is a major public-health milestone,” said Martin Fitchet, noting that infants had long “fallen through the cracks” due to a lack of suitable treatments.
Early success in Africa
The drug has already been rolled out in Ghana, where early cases highlight its life-saving potential. One infant, treated at just 12 weeks old after testing positive for malaria, has since made a full recovery.
Doctors on the ground say the availability of an infant-specific treatment is a game-changer.
A broader fight against malaria
The approval of Coartem Baby comes amid renewed global efforts to combat malaria, including new vaccines, improved diagnostic tools, and next-generation mosquito nets.
Novartis has pledged to supply the treatment on a largely not-for-profit basis in high-burden regions—an important step toward ensuring access for vulnerable populations.
With this milestone, global health leaders believe the tide may finally be turning against a disease that has plagued humanity for centuries—starting with its youngest and most vulnerable victims.
