WHO approves Coartem Baby for infants with malaria
Updated
Updated · The Guardian · May 2
WHO approves Coartem Baby for infants with malaria
11 articles · Updated · The Guardian · May 2
The treatment can be used in babies as small as 2kg and has already been introduced in Ghana, where malaria killed 610,000 people in 2024, mostly African under-fives.
WHO prequalification allows public-sector procurement in high-burden countries, especially in sub-Saharan Africa, after infants were previously given older children's medicines that risked dosing errors, side effects and toxicity.
Developed by Novartis and Medicines for Malaria Venture, the cherry-flavoured artemether-lumefantrine tablets will be supplied largely not for profit in endemic regions.
Amidst rising drug resistance, is this new infant malaria treatment a breakthrough or just a temporary stopgap?
Will a potential US challenge to the WHO's authority disrupt the global delivery of future life-saving medicines?
With new tools but stalled progress, what is the real obstacle preventing the world from defeating malaria?
WHO Prequalifies Coartem Baby, Closing the Treatment Gap for 30 Million Infants at Risk of Malaria
Overview
On April 24, 2026, the World Health Organization prequalified Coartem Baby, the first antimalarial medicine specifically developed for newborns and young infants weighing 2 to 5 kilograms. This milestone followed Swissmedic's approval in July 2025 and was based on the CALINA clinical trial that demonstrated the drug's safety and optimized dosing for this vulnerable group. Before Coartem Baby, infants under 5 kg were excluded from trials and treated off-label, risking under- or overdosing. The drug's infant-friendly, dispersible formulation and affordable pricing support its rollout, which began in Ghana in March 2026, aiming to reduce the high malaria mortality among young children in endemic regions.