A landmark malaria treatment specifically designed for newborns and very young children has received regulatory approval and is expected to begin rolling out across Africa within weeks.

The new drug, Coartem Baby also marketed as Riamet Baby in some regions was developed by pharmaceutical giant Novartis in partnership with the Medicines for Malaria Venture (MMV), a Swiss-based not-for-profit. It is the first malaria medication approved for children weighing less than 4.5kg (10 pounds), addressing a longstanding treatment gap for infants.

Until now, babies at risk of malaria have been treated with drugs formulated for older children, which posed significant risks, including potential overdose due to differences in how infant bodies process medication.

In 2023 alone, malaria was linked to approximately 597,000 deaths, the vast majority of which occurred in Africa. Three out of four victims were children under the age of five, highlighting the urgent need for safe, age-specific treatments.

The Swiss regulatory approval paves the way for the drug’s deployment in high-burden malaria countries. Eight African nations participated in clinical trials and are expected to be among the first to access the treatment.

Novartis CEO Vas Narasimhan described the approval as a critical milestone:

“Together with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve.”

The drug will be introduced on a largely not-for-profit basis, a move welcomed by global health advocates aiming to reduce healthcare inequalities.

MMV CEO Martin Fitchet hailed the development as a crucial addition to the antimalarial arsenal, while Dr. Marvelle Brown, an associate professor at the University of Hertfordshire, called it a potential lifesaver.

“This is a major breakthrough, particularly in sub-Saharan Africa, where over 76% of malaria deaths occur in children under five. Making this drug accessible and affordable could dramatically reduce those numbers.”