The World Health Organization (WHO) has announced it has prequalified the antimalarial drug Coartem (artemether-lumefantrine) Baby for newborns and young infants, enabling global procurement for the first time.
The therapeutic was developed through a collaboration between Medicines for Malaria Venture (MMV) and Novartis to address the unmet need in malaria care for patients under six months of age.
Coartem Baby is also known as Riamet Baby in some countries.
There were 610,000 deaths from malaria in 2024, with almost all of them in Africa and under-5s accounting for about three in four of these deaths in the region.
"This new formulation of artemether-lumefantrine represents an innovation as there are no antimalarial medicines specifically developed for the treatment of uncomplicated malaria in children from 2 to 5 kilograms body weight," said Dr Daniel Ngamije Madandi, Director, Malaria and Neglected Tropical Diseases at the WHO.
Until recently, there was no approved malaria treatment for infants under 4.5 kilograms, creating a treatment gap. These infants were often given medications meant for older children, which can lead to increased side effects 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."
"As doctors, we've tended to look for malaria in older children, but when newborn babies got sick, nobody seemed to know what to do," added Dr Emmanuel Aidoo, a paediatrician at Methodist Hospital in Ankaase, Ghana.
Having a new treatment tailor-made for infants that is well tolerated gives us confidence.
Coartem Baby was developed by Novartis with the scientific and financial support of MMV and as part of the PAMAfrica consortium, which is co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency.
"This decision takes us one step closer to ensuring that the tiniest babies have access to the first antimalarial designed specifically for them," said 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.
Novartis said that it is making the treatment available on a largely not-for-profit basis in malaria-endemic regions.