The World Health Organization has ‘pre-qualified’ Coartem® Baby, the first-ever malaria treatment for young infants of 4.5 kilograms or less.

The combination treatment, now being rolled out in Ghana, aims to fill a longstanding gap in treatments available for children under the age of 5, who constitute three quarters of the estimated 610,000 malaria deaths worldwide. 

Until now, infants with malaria have been treated with formulations intended for older children, which increase the risk of dosing errors, side effects and toxicity.” said WHO Director General Dr Tedros Adhanom Ghebreyesus speaking to reporters last week.  

“This new formulation of artemether-lumefantrine helps to close a long-standing treatment gap for some 30 million babies born each year in malaria-endemic areas of Africa.”

The artemisinin-based combination treatment, developed by Novartis together with Medicines for Malaria Venture (MMV), can be used on newborns and infants as small as 2kg.  

It was approved by the Swiss drug regulatory agency, Swissmedic in July 2025. 

WHO Pre-qualification paves way for mass procurement

But WHO’s ‘prequalification’, announced last week, is a critical step in paving the way for bulk procurement of the treatment by international agencies such as the Global Fund to Fight AIDS, Tuberculosis and Malaria for distribution in low-income countries at concessionary prices, said Pierre Hugo, MMV Vice President of Access and Product Management. 

Prequalification is WHO’s ‘stamp of approval’ assuring the quality, safety and efficacy of vaccines and medicines for major diseases like malaria, HIV/AIDS and tuberculosis. WHO’s list of prequalified products is used by UNICEF, the Global Fund, and other agencies procuring products in bulk, to inform their choices about drug and vaccine purchases. 

 “WHO prequalification is a critical milestone because it enables procurement by major global health funders… While specific procurement volumes have not yet been announced, this step paves the way for large-scale access in malaria-endemic countries,” Hugo said.

Eight other African countries joined in the Swissmedic “Marketing Authorisation for Global Health Products” (MAGHP)  process for approving the new malaria formulation, including Burkina Faso, Côte d’Ivoire, Kenya, Malawi, Mozambique, Nigeria, Uganda and Tanzania.  

The process aims to support the national regulatory agencies of low-income countries in the Swissmedic assessment, building trust and confidence that can help fast-track national marketing authorisations following Swissmedic’s approval.

Incorporating into WHO treatment guidelines next step for mass rollout 

The next important milestone will be for the medicine to be added to the WHO treatment guidelines, Hugo said. This is another requirement for Global Fund bulk procurement of new medicines and vaccines, along with registration of the treatment in national regulatory systems.  

“Coartem® Baby represents a breakthrough not just in science, but in equity, closing a long-standing treatment gap for the smallest and most vulnerable malaria patients. With WHO prequalification now secured, the focus shifts from innovation to access, ensuring that this life-saving treatment can reach newborns across malaria-endemic regions.”

Earlier this month, WHO also prequalified three new rapid diagnostic tests that can detect strains of malaria that older tests miss. 

Said Tedros, “Together with vaccines, new diagnostics and next-generation mosquito nets, it’s another step towards a malaria-free world”. 

Image Credits: MMV.