NAIROBI, Kenya— The first malaria treatment specifically developed for newborns and small babies has received regulatory approval and is expected to be rolled out across Africa within weeks—marking a critical milestone in the fight against one of the world’s deadliest diseases.
The new drug, Coartem Baby (also known as Riamet Baby), developed by Swiss pharmaceutical giant Novartis in collaboration with the Medicines for Malaria Venture (MMV), is the first malaria medication formulated for babies weighing less than 4.5kg (10 lbs).
Until now, there were no approved malaria drugs for infants, leaving caregivers and clinicians to rely on scaled-down versions meant for older children—a risky workaround that raised the threat of overdosing due to immature liver function and the unique pharmacological needs of babies.
A Major Gap Closed in Malaria Treatment
“This new drug fills a critical treatment gap for the smallest and most vulnerable patients,” said Dr Marvelle Brown, a public health expert at the University of Hertfordshire. “It is a major breakthrough in saving lives, especially in regions like sub-Saharan Africa where malaria remains a leading cause of death among children.”
Africa Hit Hardest: 597,000 Deaths in 2023
According to the latest global figures, malaria caused an estimated 597,000 deaths in 2023, with nearly 75% of those fatalities among children under the age of five—most of them in Africa.
The approval of Coartem Baby could significantly reduce those numbers by providing a safe, effective, and accessible treatment option for newborns.
“For more than three decades, we have stayed the course in the fight against malaria,” said Novartis CEO Vas Narasimhan. “We’re proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest can finally receive the care they deserve.”
Not-for-Profit Rollout in Africa
Coartem Baby has been approved by Swissmedic, the Swiss drug regulatory agency, and will be distributed on a largely not-for-profit basis.
Novartis says eight African countries that took part in the drug’s clinical trials will be among the first to access the medication.
The MMV, which helped develop the drug, is a not-for-profit public-private partnership initially backed by the British, Swiss, and Dutch governments, the World Bank, and the Rockefeller Foundation.
“The approval of Coartem Baby is a game-changer,” said MMV CEO Martin Fitchet. “It offers a long-overdue solution for a neglected group of patients and represents an important step toward eliminating malaria.”
Hope for Children with Sickle Cell and Weakened Immunity
Public health experts have also highlighted the drug’s potential to reduce mortality in babies born with sickle cell disease, who face a higher risk of dying from malaria due to compromised immunity.
“Making this drug affordable can help reduce inequality in healthcare access, especially for babies already burdened by chronic conditions like sickle cell,” said Dr Brown.
