Coartem Baby: first malaria medicine for newborns ^{CEFR B1}

Every year about 30 million babies are born in malaria-endemic parts of Sub-Saharan Africa. In July 2025 Swissmedic approved Coartem Baby, the first antimalarial formulation designed for newborns and infants under five kilograms. Novartis developed the product with the not-for-profit Medicines for Malaria Venture (MMV).

For decades health workers had to improvise with adult medicines by breaking tablets or using older-children formulations, a practice that risked underdosing and overdosing. MMV said many professionals wrongly believed maternal antibodies protected babies for months; the evidence shows that protection often fades within weeks. Newborns were also excluded from trials because of ethical concerns and the difficulty of studying them.

Regulatory capacity in several African countries was limited until recently. Swissmedic used its Marketing Authorization for Global Health Products procedure, and eight countries committed to fast-track national approvals within 90 days. MMV and partners describe the product as a public health necessity introduced largely on a not-for-profit basis.