Novartis and MMV's Coartem Baby Receives Swissmedic Approval for Malaria Treatment in Newborns and Infants

July 8, 2025
Coartem Baby, developed by Novartis and MMV, receives Swissmedic approval as the first malaria treatment for newborns, marking a major step in expanding care for infants at risk of malaria.

According to a July 8 press release, Novartis announced that Swissmedic has approved Coartem Baby (artemether-lumefantrine) as the first malaria treatment specifically developed for newborns and infants under 5 kilograms. Also known as Riamet Baby in some regions, the formulation was created in partnership with Medicines for Malaria Venture (MMV) to address a critical treatment gap for the youngest and most vulnerable patients.

The approval follows results from the Phase II/III CALINA study and marks a major step in expanding care for infants at risk of malaria, particularly in Africa where 30 million babies are born annually in malaria-endemic areas. Eight African countries participated in the regulatory assessment and are expected to follow with rapid national approvals. Novartis plans to make the treatment available on a largely not-for-profit basis.

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Janette Wider | Editor-in-Chief

Janette Wider is Editor-in-Chief for Healthcare Purchasing News.