Source: TOI
Context: Switzerland has approved Coartem Baby, the first-ever malaria treatment for newborns and infants, developed by Novartis. Eight African nations are expected to follow with fast-track approvals.
About Coartem Baby – First Malaria Drug for Infants:
- What it is?
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- A new pediatric formulation of artemether-lumefantrine, named Coartem Baby, specifically designed for infants weighing 2–5 kg (newborns to under 6 months).
- Developed by:
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- Novartis, in collaboration with Medicines for Malaria Venture (MMV) and other global health partners.
- Objective:
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- To close the treatment gap for malaria in the most vulnerable age group — newborns and very young infants, previously excluded from clinical trials and vaccination coverage.
- Key Features:
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- Dissolves easily, even in breast milk.
- Cherry-flavoured to ensure better infant compliance.
- Clinically tested dose ratio for infants with immature liver function.
- Approved under Swiss medic’s Marketing Authorisation for Global Health Products pathway.
- Will be offered largely not-for-profit in malaria-endemic countries.
- Significance:
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- Fills a critical public health gap: no malaria drugs were previously approved for babies under 4.5 kg.
- Improves safety by eliminating off-label dosing from older children’s formulations.
- Expected to be approved soon in 8 African nations: Kenya, Tanzania, Uganda, Nigeria, Malawi, Mozambique, Burkina Faso, and Ivory Coast.
- Addresses malaria risk in ~30 million newborns born annually in Africa’s endemic zones.
