By Fineline Cube 
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that it has received marketing approval from Swissmedic for its Coartem (artemether-lumefantrine) Baby, marking the first malaria medicine specifically indicated for newborns and young infants. Marketed as Riamet Baby in some countries, this breakthrough therapy was co-developed with Medicines for Malaria Venture (MMV) to address the critical treatment gap for this vulnerable patient population.
Addressing Unmet Medical Need
Previously, no antimalarial drugs were approved for infants weighing less than 4.5 kg. Healthcare providers had to adapt medications intended for older children, risking potential overdosing and toxicity. Additionally, existing malaria vaccines remain unapproved for neonatal use.
Novel Formulation and Administration
Coartem Baby features a novel formulation specifically designed for infants, supported by MMV-funded research and developed as part of the PAMAfrica consortium. The consortium is backed by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. The drug is formulated to be dissolvable, even in breast milk, and includes a sweet cherry flavor to facilitate easier administration.
Global Health Product Authorization and Accessibility
Eight African nations participated in the evaluation process for Coartem Baby. The treatment is expected to receive expedited approvals through Swissmedic’s global health product authorization pathway. Novartis plans to commercialize this pediatric treatment on a not-for-profit basis to enhance accessibility in malaria-endemic regions.-Fineline Info & Tech