Novartis receives approval for first malaria medicine for newborn babies and young infants

Core Insights - Novartis has received approval from Swissmedic for Coartem Baby, the first malaria treatment specifically for newborns and young infants, developed in collaboration with Medicines for Malaria Venture (MMV) [1][3][7] - The treatment aims to address a significant gap in malaria care for infants under 4.5 kilograms, who have previously been treated with formulations for older children, increasing the risk of overdose [3][5] - Novartis plans to introduce Coartem Baby on a largely not-for-profit basis to enhance access in malaria-endemic regions, with rapid approvals expected in eight African countries [2][6][7] Company Initiatives - Novartis has committed over USD 490 million in funding for global health R&D since 2021, focusing on malaria and neglected tropical diseases [9] - The company has delivered more than 1.1 billion treatment courses of antimalarials since 1999, primarily at no profit, including 500 million treatments for children weighing at least 5 kilograms [9] - The new treatment was developed as part of the PAMAfrica consortium, which is co-funded by various international health organizations [5] Industry Context - Approximately 30 million babies are born annually in malaria-risk areas in Africa, with infection rates in infants under 6 months ranging from 3.4% to 18.4% [4] - Malaria remains one of the deadliest diseases globally, particularly affecting children under 5 years old, who account for about three-quarters of malaria deaths in the region [6][8] - The approval of Coartem Baby is based on the Phase II/III CALINA study, which focused on optimizing the dosage for infants under 5 kilograms [6]