WHO prequalifies first-ever malaria treatment for newborns and infants, adds new diagnostic tests

The World Health Organization says it has prequalified the first malaria treatment designed for newborns and young infants, a move that could expand access to care for some of the smallest patients.

In a release published on April 24, WHO said the treatment is artemether-lumefantrine, marketed by Novartis as Coartem Baby. Novartis separately confirmed the WHO prequalification the same day.

WHO said the formulation is intended for infants weighing 2 to 5 kilograms and fills a gap that previously left many babies to be treated with medicines designed for older children.

The organization also said it had prequalified three new rapid diagnostic tests for malaria on April 14, 2026, aimed at settings where HRP2-based tests can miss infections.

WHO’s prequalification list shows the three tests from Rapigen: BIOCREDIT Malaria Ag Pf (pLDH), BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) and BIOCREDIT Malaria Ag Pf (pLDH/HRPII).

The treatment and diagnostic updates are part of a broader effort to improve malaria care in settings where the disease remains a serious public-health burden.