First-ever malaria treatment for babies approved, rollout expected in Africa soon

Despite existing treatments for older children, this newly approved formulation is the first to address the youngest and most vulnerable patients.

Experts have long warned of a “treatment gap” due to the lack of safe, approved options for infants. This gap is now expected to be addressed with the launch of Coartem Baby, also known as Riamet Baby in some countries.

The treatment was developed by Novartis in collaboration with the Medicines for Malaria Venture (MMV), a Swiss-based non-profit supported by the governments of Britain, Switzerland, the Netherlands, the World Bank, and the Rockefeller Foundation.

The formulation is designed to dissolve easily, including in breast milk, and according to a Reuters report, has a sweet cherry flavour to ease administration.

Developed with African support, set for not-for-profit distribution

Eight African countries—Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda—participated in the assessment and clinical trials of Coartem Baby. These countries are expected to be the first to approve and adopt the treatment.

Novartis plans to distribute the drug on a largely not-for-profit basis. CEO Vas Narasimhan described the approval as a pivotal moment in the global fight against malaria. “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,” the BBC quoted him as saying.

The BBC report also quoted MMV CEO Martin Fitchet who said, “Malaria is one of the world’s deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated. 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.”

Novartis originally launched Coartem in 1999. The new formulation represents a crucial step in making malaria treatment more accessible to an often-overlooked population—infants at the highest risk of severe disease and death.