Swiss regulator Swissmedic has approved Coartem® Baby (also known as Riamet® Baby), marking a historic first: an antimalarial drug specifically formulated for newborns and infants weighing 2–5 kg (approximately 4½–11 lb). This fast-tracked nod, coordinated with the WHO’s Global Health Products scheme, fills a critical treatment void in neonatal malaria care.

Developed by Novartis in partnership with the Medicines for Malaria Venture, the cherry-flavored, dissolvable formulation combines artemether and lumefantrine—proven safe and effective through the CALINA Phase II/III study in Africa, addressing infants’ unique metabolic needs. Previously, babies under 4.5 kg were given scaled-down doses of drugs designed for older children, posing overdose and toxicity risks.

Eight malaria-endemic African nations—including Kenya, Nigeria, Tanzania, and Uganda—have joined the approval process and are expected to authorize the drug within 90 days. Novartis plans to distribute Coartem Baby largely on a not-for-profit basis, supporting equitable access amid rising malaria drug resistance and shrinking global health funding.

Experts welcome the drug as a vital milestone: “This is a drug which we know is safe, we know works well,” noted malaria specialist Dr. Quique Bassat. With nearly 600,000 malaria deaths in 2023—over 95 % in Africa and most among children under five—Coartem Baby could save thousands of vulnerable lives.