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16h ago

Swissmedic Approves First Malaria Treatment for Infants Under 5 Kilograms

The breast-milk-friendly, cherry-flavored formula aims to close the treatment gap by reaching infants across eight African nations in the coming months.

Coartem Baby already has approval in the West African nation of Ghana and drugmaker Novartis said it now expects eight African countries to grant their own approvals within 90 days.
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Overview

  • Swissmedic granted fast-track authorization for Coartem Baby to treat infants weighing between 2 and 5 kilograms, making it the first approved antimalarial for this age group.
  • The dissolvable, cherry-flavored formulation can be mixed with breast milk to simplify dosing and reduce overdose risks in newborns.
  • Coartem Baby was developed by Novartis in collaboration with the Medicines for Malaria Venture and builds on the established artemether-lumefantrine therapy used in over a billion patients since 2000.
  • Eight high-burden countries in sub-Saharan Africa are reviewing the dossier and are expected to authorize the not-for-profit rollout within approximately 90 days.
  • The approval fills a critical gap that left infants under 4.5 kilograms—about 30 million born annually in malaria-endemic areas—without tailored, approved treatment.