The World Health Organization (WHO) has officially prequalified Coartem® Baby (artemether-lumefantrine), marking the arrival of the first antimalarial drug specifically designed for newborns and young infants weighing between 2 kg and 5 kg. This regulatory milestone addresses a long-standing clinical gap in treating the youngest patients affected by malaria.
WHO prequalification is a critical step that enables United Nations agencies and other international procurement organizations to purchase and distribute the medicine through donor-funded public sector programs. Historically, infants weighing less than 5 kg were often treated with off-label formulations intended for older children, which increased the risk of dosage inaccuracies and potential toxicity.
Novartis is making this new pediatric formulation available on a primarily not-for-profit basis in malaria-endemic regions. Developed in partnership with Medicines for Malaria Venture (MMV), the treatment aims to tackle the high mortality rates in Africa, where children under five account for nearly three-quarters of all malaria deaths. By providing a safe, specifically dosed option for the most vulnerable, this initiative is expected to have a significant impact on global health outcomes for newborns.