Novartis' Coartem Baby Becomes First Approved Malaria Treatment For Newborns

Novartis has announced that Swissmedic has approved Coartem® Baby (also known as Riamet® Baby), the first antimalarial medicine specifically developed for newborns and young infants weighing under 4.5 kilograms. This breakthrough, achieved in partnership with Medicines for Malaria Venture (MMV), fills a critical treatment gap for a highly vulnerable population. Until now, infants at risk of malaria were treated with drugs intended for older children, posing risks of incorrect dosing and toxicity.

“Malaria is one of the world’s deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated. The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox,” said Martin Fitchet, CEO of MMV. 

The approval process included collaboration with eight African countries through Swissmedic’s Marketing Authorization for Global Health Products initiative, setting the stage for rapid regulatory clearances across malaria-endemic regions. Novartis plans to launch the treatment on a primarily not-for-profit basis to ensure accessibility in high-need areas.

“The available malaria treatments have only been properly tested in children aged at least 6 months because smaller infants are usually excluded from treatment trials. That matters because neonates and young infants have immature liver function and metabolize some medicines differently, so the dose for older children may not be appropriate for small babies,” said Professor Umberto D'Alessandro, Director of the MRC Unit, The Gambia at the London School of Hygiene and Tropical Medicine. 

Each year, roughly 30 million babies are born in regions at risk for malaria, yet data on infection rates in this age group remains scarce due to limited clinical inclusion. Developed with funding and scientific input from MMV and the PAMAfrica consortium, the Coartem Baby formulation is infant-friendly, dissolvable in breast milk, with a cherry flavor to improve compliance and ease of use.

“For more than three decades, we have stayed the course in the fight against malaria, working relentlessly to deliver scientific breakthroughs where they are needed most. Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve,” said Vas Narasimhan, CEO of Novartis.