The first malaria treatment specifically developed for newborns and young infants has received World Health Organization (WHO) prequalification, supporting wider public sector access.
Access milestone
Novartis announced on 24 April 2026 that WHO has prequalified its infant malaria treatment for newborns and young infants weighing 2–5kg.
Developed with Medicines for Malaria Venture (MMV), the treatment addresses a long-standing gap for one of the most vulnerable malaria populations. WHO prequalification helps UN agencies and other procurement bodies assess quality, safety and efficacy when making public sector purchasing decisions.
Dr Daniel Ngamije Madandi, Director, Malaria and Neglected Tropical Diseases, WHO, said: “This new formulation of artemether-lumefantrine represents an innovation as there are no antimalarial medicines specifically developed for the treatment of uncomplicated malaria in children from 2 to 5 kilograms body weight.”
Closing the gap
Until recently, there had been no approved malaria treatment for infants weighing less than 4.5kg. Clinicians have often relied on formulations designed for older children, raising concerns around dosing, tolerability, side effects and toxicity.
Novartis says it is making the treatment available on a largely not-for-profit basis in malaria-endemic regions, having already introduced it in Ghana.
Dr Lutz Hegemann, President of Global Health, Novartis, said: “This decision takes us one step closer to ensuring that the tiniest babies have access to the first antimalarial designed specifically for them.
“We have already introduced the treatment in Ghana and are pleased to now be going further together with our partners to reach even more of the smallest malaria patients.”
Public health need
Malaria remains a major global health burden, with WHO data cited by Novartis showing 282 million cases and 610,000 deaths in 2024. Almost all deaths occurred in Africa, where children under five accounted for around three in four malaria deaths.
Dr Martin Fitchet, CEO, MMV, said: “For too long, newborns and young infants with malaria have fallen through the cracks because existing treatments were not designed with them in mind.
“This achievement shows what is possible when partners come together to translate scientific innovation into real-world impact.”
Featured image: PixieMe on Adobe Stock
