The world’s first and only malaria drug for newborns has been cleared globally, marking a crucial step towards addressing a long-standing gap in malaria care. 

Coartem (artemether-lumefantrine) Baby, developed by Medicines for Malaria Venture (MMV) and Novartis, has been prequalified by the World Health Organization (WHO) as the first and only antimalarial developed specifically for newborns and young infants weighing from two to five kilograms. 

Prequalification is a process run by the WHO to assess the quality, safety and efficacy of treatments for diseases like malaria, HIV/AIDS and tuberculosis. Prequalification outputs, including lists of prequalified products, are used by the United Nations and other procurement agencies to inform funding and purchasing decisions for the public sector. 

Until recently, there have been no approved malaria treatments for infants weighing less than 4.5 kilograms, leaving a treatment gap. The smallest infants with malaria have instead been treated with formulations intended for use in older children, which may either increase the risk of side effects and toxicity or underdosing.  

“For too long, newborns and young infants with malaria have fallen through the cracks because existing treatments were not designed with them in mind,” said Dr Martin Fitchet, CEO of MMV.  

“WHO prequalification of Coartem Baby is a major public health milestone and reflects MMV’s commitment to ensuring that even the smallest and most vulnerable patients are not left behind. This achievement shows what is possible when partners come together to translate scientific innovation into real‑world impact.”  

“This decision takes us one step closer to ensuring that the tiniest babies have access to the first antimalarial designed specifically for them,” added Dr Lutz Hegemann, President of Global Health at Novartis.  

“We have already introduced the treatment in Ghana and are pleased to now be going further together with our partners to reach even more of the smallest malaria patients.”