The first malaria treatment specifically formulated for babies and very young children has been approved for use and is expected to be rolled out in African countries within weeks.
Until now, there were no approved malaria drugs tailored for infants weighing less than 4.5kg (around 10lb), forcing healthcare providers to use formulations intended for older children—a practice that carried significant risks, including potential overdose.
In 2023 alone, malaria was linked to approximately 597,000 deaths, with nearly three-quarters of the victims being children under five years old, most of them in Africa. The lack of an infant-specific treatment has long been seen as a “treatment gap” in global malaria response efforts.
The newly approved drug, developed by pharmaceutical giant Novartis in partnership with the not-for-profit Medicines for Malaria Venture (MMV), is known as Coartem Baby (also marketed as Riamet Baby in some countries). It has been approved by Swiss authorities and will be introduced on a largely not-for-profit basis in regions with the highest malaria burden.
Eight African nations participated in the clinical assessment and trials of the drug and are expected to be among the first to benefit from its deployment.
Novartis CEO, Vas Narasimhan, described the approval as “an important moment” in global public health, while MMV CEO, Martin Fitchet, hailed it as a vital step in reducing the toll of malaria on the world’s youngest and most vulnerable.
Dr Marvelle Brown of the University of Hertfordshire’s School of Health, Medicine and Life Sciences called the development a “major breakthrough” in the effort to save young lives.
The rollout of Coartem Baby represents a significant milestone in the global fight against malaria, especially in sub-Saharan Africa where the disease continues to claim hundreds of thousands of young lives each year.
