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The first malaria treatment specifically developed for newborn babies and young infants has been approved for use. 

The approval, by Switzerland’s medical agency Swissmedic, of Coartem Baby (artemether-lumefantrine) developed by Novartis, marks a landmark moment in malaria treatment. It addresses a long-overlooked group who, until now, have had no approved medication tailored to their needs. 

The new formulation, also known as Riamet Baby in some countries, is designed for babies weighing 2-5 kilograms (4-11 pounds). This population has traditionally been excluded from clinical trials and drug development, due to concerns around metabolism, dosing safety, and trial complexity. 

With support from Medicines for Malaria Venture (MMV), Novartis developed the new infant formulation as part of the PAMAfrica consortium, co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency.  

The treatment is designed to be simple to administer, as it dissolves in liquids including breast milk and has a sweet cherry flavour so babies are more likely to take it. Eight African countries are expected to issue rapid approvals under Swissmedic’s global health authorisation scheme, potentially accelerating access in high-burden regions. Novartis has stated it will introduce the treatment on a largely not-for-profit basis in malaria-endemic countries. 

Despite global progress in malaria control, the disease remains a leading cause of child mortality. According to the World Health Organization, there were 263 million cases of malaria in 2023, resulting in nearly 600,000 deaths, the vast majority of which occurred in sub-Saharan Africa. Children under five account for around three-quarters of malaria deaths in the region. Yet the youngest infants, especially those under six months, have been largely left out of treatment trials and policies. 

Professor Umberto D’Alessandro, Director of the Medical Research Unit The Gambia (MRCG) at the ������app of Hygiene & Tropical Medicine (LSHTM), said: “Babies have been systematically excluded from clinical trials assessing the safety and efficacy of antimalarial treatments. Malaria in this group of children has been managed by administering antimalarial treatments at doses established for older children. However, such doses may not be appropriate as infants metabolise some medicine differently. 

“This approval allows for safe and appropriate treatment for babies for the first time.”   

Dr Bhargavi Rao, Clinical Associate Professor and Co-Director of the Malaria Centre at LSHTM, said: “Despite advances in preventing malaria through vector control targeting mosquitoes and innovations such as the new malaria vaccines, malaria cases continue to rise especially in regions impacted by humanitarian crises and climate change.   

“These are also the regions where malnutrition increases vulnerability to malaria and where we struggle the most to effectively protect children through other measures. Being able to safely extend treatment to babies and children under 5kg without requiring mothers to grind up tablets or needing hospital admission is an important step forward, meeting an unmet clinical need.  It will be critical however that access strategies and pricing reflect where this need is most urgent. We need transparency around what Novartis’s ‘largely not for profit’ statement means including publicly available pricing, which countries will benefit and how long for.” 

Chris Drakeley, Professor of Infection and Immunity at LSHTM, said: “This announcement comes at a crucial time for malaria given the recent reductions in funding. This specific paediatric formulation is an important addition for malaria control programmes being able to provide life time curative and protective approaches to all ages in malaria endemic countries, particularly high burden settings where infants are most at risk.”