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WHO Approves First Malaria Drug for Newborns
25 Apr
Summary
- WHO prequalification grants approval for first malaria drug for newborns.
- New formulation prevents dosage errors and toxicity in infants.
- Malaria caused 610,000 deaths in 2024, mostly in Africa.

The World Health Organization announced a significant milestone on Friday by granting prequalification approval to the first malaria treatment designed specifically for newborns and infants. This new antimalarial formulation, artemether-lumefantrine, has met stringent international standards for quality, safety, and efficacy.
Until now, infants suffering from malaria were treated with formulations intended for older children, which carried a heightened risk of dosage errors, side effects, and toxicity. This development marks a critical step in combating the disease, which claimed an estimated 610,000 lives in 2024 across 80 countries.
Africa bears the brunt of malaria, accounting for 95 percent of cases and deaths, with young children under five being the most vulnerable. The WHO's prequalification is expected to facilitate public sector procurement, helping to address a long-standing treatment gap for approximately 30 million babies born annually in malaria-endemic regions of Africa. Challenges such as drug resistance and reduced aid spending continue to impede progress against malaria.