First Malaria Treatment for Infants Under 5kg Approved by Swissmedic, Targeting African Nations

A groundbreaking new medicine, Coartem Baby, the first malaria treatment specifically for newborn babies and young infants weighing less than 5 kilograms, has received approval from Swissmedic, Switzerland's regulatory authority for therapeutic products. This development, highlighted by Semafor on social media, addresses a critical gap in global health, as previous treatments were not formulated for this vulnerable patient group. The approval is expected to pave the way for rapid rollout in several high-burden African countries within weeks.

Historically, infants under 4.5 kilograms lacked a specifically approved malaria treatment, often being given formulations intended for older children. This presented significant risks, including potential overdose and toxicity due to their developing liver functions and distinct metabolic processes. Malaria remains a devastating disease, with the World Health Organization reporting 597,000 deaths in 2023, approximately three-quarters of which occurred in children under five years old, predominantly in Africa.

Coartem Baby, also known as Riamet Baby in some regions, was developed by pharmaceutical giant Novartis in collaboration with the Medicines for Malaria Venture (MMV), a Swiss-based non-profit organization. The new formulation is dissolvable, including in breast milk, and features a sweet cherry flavor to facilitate easier administration for very young patients. Its approval is based on findings from the Phase II/III CALINA study, which investigated a new ratio and dose suitable for metabolic differences in infants weighing between 2 and 5 kilograms.

Novartis plans to introduce Coartem Baby on a largely not-for-profit basis to ensure broad access in malaria-endemic areas. Following the Swissmedic approval, eight African nations

—Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda—are anticipated to grant rapid approvals within approximately 90 days, having participated in the assessment process. Ghana has already approved the medicine, signaling its readiness for distribution.

This approval marks a significant milestone in the ongoing fight against malaria, offering a tailored solution for the youngest and most vulnerable population. Novartis CEO Vas Narasimhan emphasized the company's long-standing commitment to malaria research, stating, "Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies." The introduction of Coartem Baby complements existing anti-malarial tools like vaccines and bed nets, furthering global efforts to reduce the disease's immense toll.