WHO Prequalifies First Infant-Specific Malaria Treatment

Coartem Baby Gets WHO Approval: A Step Forward in Malaria Treatment for Infants

The World Health Organization (WHO) approved Coartem Baby, the first malaria treatment made for infants, signaling progress in treating the disease among young patients. This development fills a gap in pediatric malaria care, where older child treatments were often used for babies, causing dosing mistakes and side effects. The drug, made by Novartis and the Medicines for Malaria Venture (MMV), has artemether and lumefantrine, two antimalarial drugs approved for infants as young as 2kg (4.4lb). The dissolvable form, flavored with sweet cherry and mixed into breast milk, makes it easier to give to newborns. This approval follows Swissmedic’s approval on July 8, 2025, allowing global distribution in areas where malaria is common.

A Decade of Research and Advocacy Led to Coartem Baby’s Approval

“Newborns and young infants with malaria have been overlooked because there were no tailored treatments.”

Coartem Baby’s approval took over a decade to achieve, fueled by growing evidence that infants under six months are not immune to malaria. Doctors once believed that maternal immunity during pregnancy and breastfeeding protected young children, leading to underestimating malaria’s effect on this group. Global data from 2024 showed 610,000 malaria-related deaths, with three-quarters in Africa. This data pushed research into infant-specific treatments, leading to Coartem Baby. The drug came after years of advocacy by groups like MMV, which pointed out the lack of pediatric options in clinical trials.

Partnership and Trials for Coartem Baby

Coartem Baby was developed by Novartis, MMV, and the PAMAfrica consortium. It went through phase 2/3 trials in eight African countries, including Ghana, Kenya, and Uganda, where it worked well for infants as young as 2kg (4.4lb). These trials, supported by Swissmedic’s Marketing Authorization for Global Health Products (MAGHP) program, helped get quick approvals in those nations. The dissolvable form was made to meet the needs of newborns, who had no safe, dosed treatment before.

Challenges in Making the Drug Available

While the WHO approval is a big win, experts say challenges remain in making the drug accessible. Dr. Martin Fitchet of MMV said, ‘Newborns and young infants with malaria have been overlooked because there were no tailored treatments.’ Logistical issues like getting the drug to remote areas, cost, and training healthcare workers could slow its use. The drug needs cold chain storage to stay effective, which is tough in low-resource areas. Also, the risk of counterfeit drugs in places with weak regulations could hurt its impact. For example, in Ghana, where it was first used, healthcare workers reported delays in getting supplies, showing the need for strong distribution networks.

Real-World Impact and Next Steps

“'Having a treatment made for infants gives us confidence,'”

The drug’s effect is shown by Baby Wonder, a Ghanaian infant who recovered after being treated with Coartem Baby. According to The Guardian article, Baby Wonder’s recovery proved the drug works in real cases, validating its clinical trials. This case shows how Coartem Baby can save lives in areas where malaria is a major cause of child deaths. The WHO estimates 1.5 billion people in 93 countries are at risk of malaria, with infants still the most vulnerable. Experts urge governments and donors to focus on improving infrastructure and training healthcare workers to make the most of the drug. As Dr. Emmanuel Aidoo, a Ghanaian pediatrician, said, ‘Having a treatment made for infants gives us confidence,’ but added, ‘Changes in healthcare delivery are just as important.’ The approval of Coartem Baby is not just a medical win but a call for global health fairness.

Setting a New Standard for Pediatric Medications

The WHO’s Child-Centric Drug Development report highlights issues in pediatric medicine, noting that 70% of existing drugs for children are adapted from adult versions, often leading to dosing errors and lower effectiveness. Coartem Baby’s success shows it’s possible to make age-specific treatments, setting a new standard for future drug development. This approach fits with global health goals, stressing the need for tailored solutions for vulnerable groups. The drug’s approval also shows how partnerships between drug companies, NGOs, and regulators can overcome development and distribution challenges.