Swissmedic has approved Coartem Baby (artemether‑lumefantrine), the first-ever malaria treatment officially licensed for newborns and infants weighing under 4.5 kg. Previously, this critical demographic had no tailored therapy, relying on adult or older child formulations that risked overdose or toxicity.

Targeting the Most Vulnerable Group
Approximately 30 million babies are born annually in malaria-endemic regions across Africa, with infection rates between 3.4 % and 18.4 % in infants under six months. Coartem Baby fills a vital gap, offering a safe, approved treatment designed specifically for early childhood.

Designed for Infant Safety and Convenience
Produced by Novartis in collaboration with the Medicines for Malaria Venture (MMV), Coartem Baby is an infant-friendly liquid formulation, reducing dosing errors and improving adherence among health workers treating young patients in challenging field settings.

Rapid Adoption Planned Under Global Health Scheme
Eight African countries participating in Swissmedic’s Global Health Products pathway are set to implement rapid approvals. Novartis plans to distribute the medicine on a mainly not-for-profit basis, prioritizing access in regions most affected by infant malaria.

A Long-Awaited Breakthrough in Malaria Care
This approval marks a milestone no prior antimalarial had formal regulatory approval for infants under 4.5 kg. Now, even the youngest patients can receive clinically validated treatment, reducing infant mortality and improving early health outcomes.

Global Health Impact and Scaling Up Care
Targeted rollout across Africa means tens of millions of infants will soon have access to a safe, effective, and regulated antimalarial. Coartem Baby represents a major advancement in closing the childhood treatment gap in malaria-endemic countries.