First Global Malaria Treatment Approved for Newborns and Infants by WHO

The World Health Organization (WHO) has prequalified the first antimalarial treatment specifically developed for newborns and young infants, marking a significant advancement in global malaria control efforts.

The treatment, Coartem® (artemether-lumefantrine) Baby, is designed for infants weighing between 2 and 5 kilograms and is the first malaria medicine formulated for this age group. Until now, infants with malaria had to be treated with medicines intended for older children, increasing the risk of dosing errors and adverse effects.

WHO prequalification confirms that the medicine meets international standards for quality, safety, and efficacy. This designation enables United Nations and other procurement agencies to purchase and distribute the treatment through public health systems in malaria-endemic regions.

WHO Director-General Dr Tedros Adhanom Ghebreyesus emphasized the importance of the development, stating that new vaccines, diagnostic tests, mosquito nets, and effective medicines adapted for the youngest patients are helping to turn the tide against malaria.

The prequalification of Coartem® Baby follows its approval by Swissmedic in July 2025 as the first malaria medicine for newborns and young infants. The treatment was developed through a collaboration between Novartis and Medicines for Malaria Venture (MMV).

Novartis is making the treatment available on a largely not-for-profit basis in malaria-endemic regions to support broader access through public sector procurement.

On 14 April 2026, WHO also prequalified three new rapid diagnostic tests (RDTs) designed to address emerging diagnostic challenges for malaria, including tests that detect the HRP2 protein associated with Plasmodium falciparum.

The development addresses a long-standing treatment gap for an estimated 30 million babies born each year in malaria-endemic areas of Africa, who previously had no antimalarial medicine specifically designed for their weight and age group.

WHO prequalification is a critical step toward enabling widespread access to quality-assured malaria treatment for newborns and young infants through donor-funded and public sector purchasing mechanisms.

The announcement comes ahead of World Malaria Day on 25 April 2026, underscoring global efforts to eliminate malaria through sustained political and financial commitment.

With this prequalification, WHO and its partners aim to close a critical gap in malaria care, ensuring that even the youngest and most vulnerable patients have access to safe, effective, and age-appropriate treatment.

This article is based on verified information from the World Health Organization, Novartis, and Medicines for Malaria Venture announcements dated April 24, 2026, and April 8, 2025, as well as WHO updates on diagnostic test prequalifications from April 14, 2026.