Global Health Milestone: WHO Prequalifies First-Ever Malaria Treatment for Newborns

Novartis has achieved a historic breakthrough in pediatric medicine with the World Health Organization (WHO) prequalification of Coartem® Baby. This specialized formulation of artemether-lumefantrine is the first and only antimalarial treatment designed specifically for newborns and young infants weighing between 2 and 5 kilograms.

Prior to this milestone, a critical treatment gap existed for the world’s smallest patients. Healthcare providers often had to adapt dosages meant for older children, a practice that carried significant risks of toxicity and side effects. Developed in collaboration with Medicines for Malaria Venture (MMV), Coartem® Baby ensures that infants who previously “fell through the cracks” now have access to a safe, accurately dosed, and effective therapy.

Expanding Access to Vulnerable Infants

With WHO prequalification, the door is now open for United Nations agencies and global procurement funds to purchase and distribute the medication at scale. To ensure maximum impact, Novartis is providing the treatment on a largely not-for-profit basis in malaria-endemic regions. Following a successful rollout in Ghana, this regulatory green light is expected to accelerate the delivery of life-saving care to infants across the globe.