The World Health Organization (WHO) has granted prequalification to the first malaria treatment specifically developed for newborns and young infants. This development aims to improve access to vital medication for one of the most vulnerable populations affected by the disease. Novartis announced that the infant malaria treatment is now available for newborns and young infants weighing between 2 and 5 kilograms.
Developed in partnership with Medicines for Malaria Venture (MMV), this new formulation addresses a critical gap in malaria treatment. Previously, there were no approved malaria drugs for infants weighing less than 4.5kg, forcing clinicians to use formulations intended for older children, raising concerns about dosing and side effects.
The WHO prequalification is a key step for UN agencies and other procurement bodies to assess the quality, safety, and efficacy of medicines for public sector purchasing decisions. Novartis is making the treatment available on a largely not-for-profit basis in malaria-endemic regions. Ghana has already introduced the treatment.
Malaria continues to be a major global health challenge, with 282 million cases and 610,000 deaths reported in 2024, according to WHO data. The vast majority of these deaths occurred in Africa, with children under five accounting for a significant proportion.