06:07 AM EDT, 07/08/2025 (MT Newswires) -- Novartis ( NVS ) said Tuesday its Coartem Baby has received approval from Swissmedic for the treatment of malaria for newborns and young infants.

The approval was based on a phase 2/3 study, which looked into a new ratio and dose of Coartem to account for metabolic differences in babies under five kilograms. According to the company, the treatment was found to be dissolvable, including in breast milk.

Eight African countries, namely Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda, also participated in the assessment and are now expected to issue rapid approvals under the Swiss agency's marketing authorization for global health products procedure, the company said.

The drug, developed in collaboration with Medicines for Malaria Venture, is a new dose designed for babies and infants. It was developed as part of the PAMAfrica consortium, which is co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency.