GENEVA, July 10 — Switzerland’s health regulator Swissmedic granted marketing authorisation on Tuesday for Novartis Riamet Baby, also known as Coartem Baby, a novel antimalarial medicine specifically designed for infants weighing two to five kg, reported Xinhua.
In a statement, Swissmedic said the authorisation procedure involved close collaboration with national regulatory authorities from eight African countries. The World Health Organisation (WHO) Global Malaria Programme 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, said 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 flavour to make it easier to administer.
According to the World Malaria Report 2024 published by the WHO, the African Region accounted for about 94 per cent of malaria cases and 95 per cent of malaria deaths globally in 2023, with 76 per cent of all deaths in this region consisting of children under the age of five. — Bernama-Xinhua
