Landmark WHO Approval for First Newborn-Specific Malaria Drug
The World Health Organization (WHO) has approved the first malaria treatment developed exclusively for newborns and very young infants. The approval, announced on April 24, confirms that the treatment meets international standards for safety and effectiveness.
WHO Director-General Dr. Tedros Adhanom Ghebreyesus hailed the progress being made in the fight against the disease: "For centuries, malaria has stolen children from their parents, and health, wealth, and hope from communities". The WHO chief added that new vaccines, diagnostic tests, and next-generation mosquito nets are also helping to turn the tide.
The new artemether-lumefantrine formulation was developed through a partnership between Novartis and the Medicines for Malaria Venture (MMV), under the PAMAfrica consortium. In August 2025, the Africa Centres for Disease Control and Prevention (Africa CDC) praised the Swiss drug regulator's approval of the formulation while commending eight African countries for their participation in clinical trials.
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The Africa Centres for Disease Control and Prevention (Africa CDC) has welcomed the approval of the first malaria treatment designed for newborns and infants under five kilograms, calling it a "major step forward".
The new artemether-lumefantrin formulation for children was developed through a partnership between Novartis and
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New mothers in a Lilongwe hospital (file photo).
