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

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.