Switzerland approves first malaria drug for infants
Coartem Baby is a reformulation of the existing Coartem (artemether-lumefantrine) combination therapy. The new formulation was developed through a collaboration between Novartis and the Medicines for Malaria Venture (MMV), with support from the PAMAfrica consortium.
The clinical development program was co-funded by the European & Developing Countries Clinical Trials Partnership and the Swedish International Development Cooperation Agency. The approval was based on positive data from the Phase II/III CALINA study, which demonstrated that Coartem Baby has a pharmacokinetic profile suitable for infants under 5 kilograms and exhibits good efficacy and safety.
Global Health Impact
Malaria remains one of the world's deadliest diseases, particularly among children under five years old in Africa. In 2023, there were an estimated 36 million pregnancies in 33 African countries where malaria is widespread, with about one in three mothers infected with malaria during pregnancy, raising the risk of transmission to their newborns.
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