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16h ago

Swissmedic Approves First Malaria Treatment for Newborns Under 4.5 kg

Novartis will roll out the cherry-flavored, dissolvable therapy largely at cost after Ghana’s authorization with approvals expected from eight other African regulators within 90 days.

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 approval of Coartem Baby on July 8 for infants weighing 2–5 kilograms, filling a treatment void for newborns under 4.5 kg.
  • Ghana has already adopted the sweet-flavored, breast-milk-compatible formulation and eight trial countries are set to approve it based on Swissmedic’s clinical data.
  • Coartem Baby was co-developed by Novartis and the Medicines for Malaria Venture to replace off-label use of older-child antimalarials that carried overdose risks in very young patients.
  • The dissolvable, cherry-flavored tablet is designed to simplify dosing and improve adherence among caregivers in remote and resource-limited settings.
  • Novartis plans a largely not-for-profit distribution in malaria-endemic regions to ensure the treatment reaches the youngest and most vulnerable infants.