On the eve of World Malaria Day, the World Health Organization (WHO) has officially prequalified Coartem® Baby — the first-ever antimalarial treatment specifically engineered for newborns and infants weighing between 2 - 5kg. For decades, the smallest infants — approximately 30 million born annually in high-risk zones — fell through the cracks of global medicine. Without a dedicated formulation, clinicians were forced to scale down adult tablets, a practice fraught with risks of toxicity and inaccurate dosing. Coartem® Baby changes that entirely.
Developed by Novartis in collaboration with Medicines for Malaria Venture (MMV), it is a dispersible artemether-lumefantrine formulation built from first principles for the biology of a newborn — not adapted, not approximated, purpose-built. Three things make today's announcement immediately consequential. WHO prequalification is the green light that international procurement agencies like UNICEF and the Global Fund need to begin large-scale purchasing and distribution. Early integration in Ghana has already delivered the real-world safety and tolerability data that proves the treatment works in the field. And Novartis has committed to making Coartem® Baby available on a largely not-for-profit basis across malaria-endemic regions — ensuring access for all.