Novartis Pharma AG, affiliated to Swiss drug major Novartis AG (NVS), announced Tuesday that Coartem (artemether-lumefantrine) Baby has been approved by Swissmedic as the first malaria medicine for newborns and young infants.
The company added that eight African countries 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.
Novartis plans to introduce the infant-friendly treatment on a largely not-for-profit basis to increase access in areas where malaria, a life-threatening disease caused by a parasite and spread to humans by some types of mosquitoes, is endemic.
The new treatment, also known as Riamet Baby in some countries, was developed in collaboration with Medicines for Malaria Venture or MMV to treat the potentially deadly mosquito-borne disease.
The Swissmedic approval is based on the Phase II/III CALINA study, which investigated a new ratio and dose of Coartem (artemether-lumefantrine) to account for metabolic differences in babies under 5 kilograms.
According to the most recent WHO data, there were 263 million cases of malaria and 597,000 deaths in 2023, almost all of them in Africa. In the region, children under 5 years old accounted for about three in four malaria deaths.
Until now, there has been no approved malaria treatment for infants weighing less than 4.5 kilograms, instead they have been treated with formulations intended for use in older children. This might increase the risk of overdose and toxicity. Malaria vaccines are also not approved for the youngest babies.
Novartis developed the new dose strength designed for young infants with the scientific and financial support of MMV, and 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.
Martin Fitchet, CEO of MMV, said, "Malaria is one of the world's deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated.. The approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox."
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