NEW YORK, May 1 – The World Health Organization has prequalified the first antimalarial treatment specifically formulated for newborns and infants weighing between 2 and 5 kilograms, marking a new development in malaria treatment for the most vulnerable age group.
Announced on April 24, 2026, ahead of World Malaria Day, the prequalification of artemether-lumefantrine confirms that the medicine meets international standards of quality, safety, and efficacy.
The newly introduced combination of artemether and lumefantrine is the first antimalarial formulation that is safe for babies weighing less than 5 kilograms (11 pounds).
Until now, infants have been treated with drugs developed for older children, which expose the newborns to risks of dosing errors and toxicity.
The WHO approval allows countries to authorize the drug even if they lack the capacity to conduct full clinical trials.
The approval also enables UN agencies to procure and distribute the treatment in malaria-endemic areas, subject to government approval.
Malaria has a major impact during pregnancy. Each year, it contributes to an estimated 10,000 maternal deaths, 200,000 stillbirths and around 550,000 babies being born with low birth weight, according to the WHO.
Since 2000, global efforts have led to significant progress, with an estimated 14 million deaths averted, the WHO says.
Nevertheless, malaria remains a major global health challenge, with about 282 million cases and over half a million deaths reported in 2024