WHO prequalifies Novartis Coartem Baby for newborn malaria treatment
WHO has prequalified Coartem Baby, the first malaria treatment developed for newborns and young infants weighing 2 to 5 kilograms. The decision opens access through public procurement and donor-funded programs.
The World Health Organization has prequalified Coartem Baby, the first and only malaria treatment developed specifically for newborns and young infants weighing between 2 and 5 kilograms. This milestone paves the way for broader access through public sector procurement and donor-funded programs, addressing a long-standing treatment gap.
Malaria remains a life-threatening disease, with children under five accounting for the majority of deaths in Africa. Until now, infants under 4.5 kilograms had no approved treatment options, often receiving medicines designed for older children, which carried risks of side effects and toxicity. Coartem Baby, also known as Riamet Baby in some countries, was developed in collaboration with Medicines for Malaria Venture and is being made available largely on a not-for-profit basis in endemic regions.
Clinical experts highlighted the importance of this innovation, with a pediatrician in Ghana noting that having a treatment tailored for infants provides confidence to physicians who previously lacked safe options. WHO officials emphasized that the formulation represents a breakthrough in ensuring the smallest and most vulnerable patients are not left behind.
Novartis has already introduced the therapy in Ghana and plans to expand access across malaria-endemic countries. The company has delivered more than 1.1 billion courses of its antimalarial Coartem since 1999 and continues to invest in new compounds to combat drug resistance. The WHO prequalification ensures that procurement agencies can now include Coartem Baby in their supply chains.