Finally: A malaria drug made just for babies has been approved—here’s why it matters

The first-ever treatment for malaria in young babies and infants has been approved.

On Tuesday, Novartis announced it had received approval for the treatment, Coartem Baby (known as Riamet Baby in some countries), in Switzerland. Eight African countries, who participated in the assessment, are also expected to quickly approve the treatment.

Novartis worked in collaboration with the Medicines for Malaria Venture (MMV), a Swiss-based nonprofit that works to prevent and develop treatments for the mosquito-borne disease, on the drug. Until now, malaria treatments have only been tested in children at least 6 months old, and no drug had been an approved malaria treatment for infants under 9.9 pounds (4.5 kilograms). And, because there had been no drug designed specifically for babies and small children, treatment has involved the very young taking treatments designed for more developed bodies. It also led to what Novartis called a “treatment gap” for the age group.

“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,” said Novartis CEO Vas Narasimhan in a press release.

Narasimhan continued, “For more than three decades, we have stayed the course in the fight against malaria, working relentlessly to deliver scientific breakthroughs where they are needed most. 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.”

According to Novartis, infection rates in Africa range from 3.4% and 18.4% in infants younger than six months old. In 2023, malaria caused around 597,000 deaths, most of which were in Africa, per the World Health Organization. Three-quarters (76%) of those deaths were in children under the age of 5. Martin Fitchet, CEO of MMV, said in the press release, “Malaria is one of the world’s deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated.” Fitchet continued, “The approval of Coartem Baby provides a necessary medicine with an optimised dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.”

In recent years, malaria vaccine development has been accelerated. Still, there have been significant financial, logistical, and social hurdles, in deployment to the most vulnerable. However, Novartis says it plans to introduce its drug on a largely not-for-profit basis in order to help hard-hit “endemic” areas fight the illness.