Swiss health regulator approves first antimalarial for infants weighing 2-5kg
Jul 10, 2025
Geneva [Switzerland], July 10: Switzerland's health regulator Swissmedic has granted on Tuesday marketing authorization for Novartis Riamet Baby, also known as Coartem Baby, a novel antimalarial medicine specifically designed for infants weighing 2-5kg.
In a statement, Swissmedic said the authorization procedure involved close collaboration with national regulatory authorities from eight African countries. The World Health Organization (WHO) Global Malaria Program also participated in the scientific assessment. The next step is to ensure timely national access after the collaborative assessment.
Before the introduction of Coartem Baby, there was no approved malaria treatment for infants weighing less than 4.5 kg. As a result, these newborns were often treated with formulations intended for older children, which may increase the risk of overdose and toxicity, according to Novartis.
The new treatment, "ensuring even the smallest and most vulnerable can finally receive the care they deserve," is dissolvable, including in breast milk, and has a sweet cherry flavor to make it easier to administer.
According to the World Malaria Report 2024 published by the WHO, the WHO African Region accounted for about 94 percent of malaria cases and 95 percent of malaria deaths globally in 2023,with 76 percent of all deaths in this region among children under the age of five.
Source: Xinhua News Agency
