Swissmedic has approved Coartem Baby, the world’s first malaria treatment designed for newborns weighing 2–5 kg. Developed by Novartis and Medicines for Malaria Venture (MMV), the drug will soon be made available in eight African countries and aims to address a long-standing gap in infant malaria care.

Key Points:

• Coartem Baby, a cherry-flavored, dissolvable version of artemether-lumefantrine, is formulated specifically for babies under 5 kg.
• Swissmedic approved the drug on July 8, 2025, under its Global Health Products pathway, marking a historic first for malaria care in infants.
• Eight African countries—including Kenya, Nigeria, and Uganda—are expected to approve the drug within 90 days of Swiss clearance.
• Before this, babies below 4.5 kg had no approved malaria medicine and were treated with imprecise, fractional doses meant for older children.
• Novartis plans to distribute the drug largely on a not-for-profit basis in malaria-endemic regions, addressing urgent healthcare gaps for vulnerable infants.