First antimalarial drug designed for babies approved by WHO

BREAKTHROUGH

The World Health Organization (WHO) recently announced the prequalification of the first malaria treatment specifically developed for newborns and young infants weighing between 2 and 5 kilograms [1]. This novel antimalarial medication called Coartem® (artemether-lumefantrine) Baby (also known as Riamet® Baby in some countries) was created by Novartis [2]. It is part of the PAMAfrica consortium, which is co-funded by the European & Developing Countries Clinical trials partnership, and the Swedish International Development Cooperation Agency, with the financial and scientific assistance of Medicines for Malaria Venture [2]. The WHO’s prequalification of this drug ensures that the treatment is safe, effective, and adheres to strict quality standards, while also enabling public sector procurement [3].

WHY IT MATTERS

Until now, there were no approved treatments for malaria specifically designed for infants weighing less than 4.5 kilograms [1] [2]. Infants experience physiological changes that affect how their bodies interact with anti-malarial drugs, which can alter both the safety and effectiveness of malaria treatment [4]. Additionally, infants are at a higher risk of drug-related vomiting and have distinct parameters on how their bodies interact with antimalarial drugs that differ from those of older patients[4]. Formulations intended for larger and older children have been used to treat the youngest newborns with malaria, and while these treatments are generally safe and effective, they sometimes result in drug toxicity, treatment failures, adverse effects, and dosing errors [1] [2][4]. Treatment guidelines and pharmacological interventions for malaria have not adequately addressed the needs of this vulnerable age group.

Coartem® Baby serves as a major step in finally addressing this age group in the global fight against malaria, specifically on the African continent. According to the WHO, in 2024, about 95% of all malaria cases and 95% of malaria deaths globally occurred in Africa, and children under 5 years of age accounted for about 76% of all malaria deaths in the region. Malaria is a life-threatening disease mostly spread to people through the bites of infected female Anopheles mosquitoes, and among the five Plasmodium parasite species that cause malaria in humans, P. falciparum is the deadliest and the most prevalent on the African continent [5].

Cerebral Malaria (CM), the most severe neurological complication of infection with the P. falciparum species, is characterized by impaired consciousness, with coma being the most severe manifestation [6]. Its mortality rate is high, and some surviving patients sustain brain injury, which can lead to long-term decreased mental function, epilepsy, and other neurological deficits. These conditions occur in around 10%-30% of children who survive CM [6][7]. Children are disproportionately affected by this disease, particularly in endemic areas of Africa, where CM is responsible for roughly 400,000 annual fatalities among African children, constituting over 90% of all malaria-related deaths[8].

Artesunate (Intravenous or Intramuscular) is recommended by WHO as the drug of choice for severe malaria [4], but as mentioned earlier, some complications may occur when administered to infant patients. Thus the development and implementation of this malaria treatment for young infants and newborns could play a pivotal role in the fight against all forms of malaria.

“As doctors, we’ve tended to look for malaria in older children, but when newborn babies got sick, nobody seemed to know what to do. Having a new treatment tailor-made for infants that is well tolerated gives us confidence.” - A pediatrician at Methodist Hospital in Ankaase, Ghana [2].

WHAT’S NEXT

Integrating Coartem® alongside existing malaria vaccines and other prevention strategies needs to consider financial, geographical and cultural barriers to reaching communities with high burden of malaria by adhering to the Addis Declaration on Immunization. “Unavailability and high cost of treatment” cannot continue to contribute to high mortality rates in children due to malaria when effective treatments are available.

References

[1].World Health Organisation. WHO Prequalifies first-ever Malaria Treatment for Newborns and infants, Adds New Diagnostic Tests [Internet]. Who.int. World Health Organization: WHO; 2026. Available from: https://www.who.int/news/item/24-04-2026-who-prequalifies-first-ever-malaria-treatment-for-newborns-and-infants-adds-new-diagnostic-tests

[2].Medicine For Malaria Venture. WHO Prequalification of Coartem® Baby Marks Breakthrough in Treating Malaria in Newborns and Young Infants | Medicines for Malaria Venture [Internet]. Medicines for Malaria Venture. 2026. Available from: https://www.mmv.org/news-resources-search/who-prequalification-coartemr-baby-marks-breakthrough-treating-malaria

[3].World Health Organization. Prequalification of Medicines by WHO [Internet]. www.who.int. 2026. Available from: https://www.who.int/news-room/fact-sheets/detail/prequalification-of-medicines-by-who

[4].Kalkman LC, Hänscheid T, Krishna S, Kremsner PG, Grobusch MP. Antimalarial Treatment in Infants. Expert Opinion on Pharmacotherapy. 2022 Sep 29;23(15):1711–26

[5].World Health Organization. Malaria [Internet]. World Health Organization. 2024. Available from: https://www.who.int/news-room/fact-sheets/detail/malaria

[6].Idro R, Marsh K, John CC, Newton CRJ. Cerebral Malaria: Mechanisms of Brain Injury and Strategies for Improved Neurocognitive Outcome. Pediatric Research. 2010 Oct;68(4):267–74.

[7].Akintunde JK, Oluwajembola AM, Oladosu MA, Akintunde DG, Akintunde OG, Ojo AE, et al. Cerebral Malaria in resource-limited African regions: Diagnostic and Therapeutic Challenges. Infectious Medicine [Internet]. 2026 Apr 23;5(2):100255. Available from: https://www.sciencedirect.com/science/article/pii/S2772431X26000213#bib0015

[8].Beniwal P, Joshi J, Kaur S. A Comprehensive Review of Cerebral Malaria. Journal of Parasitic Diseases. 2024 Nov 15;49:257–72.